5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs August 03-05, 2015 Florida, USA

Biography:

Elizabeth Rivera is a technical service specialist for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). Currently, she provides technical support in the areas of formulated detergents, disinfectants for critical environments, and sterility assurance products. Her primary focus is on the proper selection of detergents, disinfectants, and sterilization assurance products including the technical support in implementing or using these in the pharmaceutical, biopharmaceutical, cosmetics, medical devices, dietary supplements, and others related. In addition, she lectures at technical educational forums, such as IPA, Interphex, ExpoFYBI, PDA, ISPE, ETIF, Expofarma, and Executive Conference. She has published articles related to cleaning. She earned a Bachelor and Graduate degree in Chemical Engineering from the University of Puerto Rico.

Abstract:

Following the release of the US FDA 1993 Cleaning Validation guide, the European Union, Health Canada and other countries issued similar guides to provide insight to the industry on how to comply with the regulations of the area (US FDA, 1993; PIC/S, 2009; Health Canada, 2008). These guidance documents place focus on validation, ensuring manufacturing control of the cleaning process. The design phase and post validation monitoring stages are factored into the process, but are not emphasized in the regulatory guides or in the industry practices. In 2008, the US FDA issued the process validation guide focusing on the life cycle approach with three main elements: Stage 1: Process Design- The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. This stage ensures that the variables within the process are identified and critical variable limits are defined Stage 2: Process Qualification- During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. This stage verifies the process, as designed, produces the expected results Stage 3: Continuous Process Verification- Ensures that critical variables are monitored and the process remains in a state of control during routine production. These three elements are the building blocks to a harmonized approach to process validation and subsequently, cleaning validation. This presentation provides an overview of the traditional cleaning validation concepts as it applies to the process life cycle approach. The process life cycle model is a significant change in how we view cleaning validation. The process life cycle model provides a better understanding of the design and monitoring of the cleaning process and ensures a more robust cleaning validation program. This model also provides a means of addressing product risk using scientifically based decisions when process deviations and non-conforming results occur during the cleaning process.

Biography:

Michael Drues, PhD, is the President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including (but not limited to): stimulating & innovative educational programming, brain-storming sessions, prototype design, product development, bench top & animal testing, regulatory strategy & clinical trial design, FDA presentation preparation & defense, reimbursement, clinical acceptance, business development & technology assessment. He received his BS, MS, and PhD degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world. He is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the US Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world. Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, he teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination.

Abstract:

The premarket notification, better known as the 510 K, is the most common regulatory pathway medical device manufacturers use to bring new medical devices to market. But because of a few highly publicized problems with some medical devices, 510k submissions are experiencing greater regulatory scrutiny prior to clearance. Although most submissions are eventually cleared, nearly 75% of first-time 510 k applications are rejected leading to review times of 114 days in 2014. This creates costly delays for medical device manufactures many of which could be minimized if not avoided completely! One of the areas receiving the greatest regulatory scrutiny is the substantial equivalence argument. Simply put without a strong substantial equivalence argument, your 510k submission may not be successful. But what does substantial equivalence really mean and how do I show it? How do I use not just what the regulation says but also what it does not say to my advantage? Using the case study approach, these questions and others will be presented in an interactive fashion. Following this presentation, participants will: • understand the regulatory requirements of substantial equivalence and how to use them to your advantage • learn to design a substantial equivalence regulatory strategy using regulatory logic and how to defend it • appreciate the split- and multi-predicate strategies and how and when to use each • be aware of several new FDA guidance documents and how to use them to your advantage • discuss the proposed changes currently under debate and what the future may hold for the 510 K program Bottom line: Knowing what the regulation says, although it’s a good start, is not enough – you must know how to use it to your advantage!

Biography:

Mariam Aslam has 10 years of Regulatory Affairs experience. Her current role is working as a Senior Consultant at PAREXEL International, United Kingdom. Her experience includes working with conventional medicines, herbal medicines, cosmetics and medical devices regulations. She studied a degree in Chemistry at the Manchester Metropolitan University in the UK. She also attended and participated as a moderator and speaker at the OMICS Group Inc 4th International Conference on Pharmaceutical Regulatory Affairs (8-10 September 2014) in Raleigh, NC, USA. Her speech was on Herbal Medicines: Product Licence to Traditional Herbal Registration in the UK.

Abstract:

Regulatory Intelligence (RI) is likely to have been practiced in some way or other from when regulations first came in to existence. In the recent years, RI has become more of a phenomenon in the pharmaceutical regulatory sector. Although the brilliance of this concept is still evolving, two definitions have been created for RI; one from the Drug Information Association’s Regulatory Intelligence Network Group (DIA RING) and the EU Regulatory Intelligence Group (EU RING). The DIA RING definition is: ‘The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation.’ The EU RING definition is: Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities – to the regulatory strategy. The process is driven by business needs and linked to decisions and actions. However you interpret these definitions, RI key aspect is applying the acquired knowledge from drug discovery to post approval. A vast amount of years and cost is invested in getting the drug on the market. Then when it gets to the market, what happens next? This is when the importance of RI ensures the best regulatory strategy, so that your drug’s safety, quality and efficacy is maintained during its lifecycle.

Biography:

Antonio Trejo Diaz is a Regional Director Regulatory Affairs - Latin America Pharmaceuticals, Mexico

Abstract:

The emerging markets represent an important opportunity to the health care industry for both the access to an increasing population and the benefits of countries that are growing on a rate above the developed countries. As part of this group of counties, Brazil and Mexico concentrate the interest of the Health Care companies in Latin America but face an important regulatory problem, the long review times before granting a MA approval and the existence of country specific requirements that differ from the core dossiers develop for EU and US. During this review the actions being taken by the Mexican Government in order to reduce the review and approval timelines by the creation of an “External review” process and the implementation of “recognition schemes” are analyzed. Representatives from both the industry and external reviewers will share their experience and expectations and an assessment of the opportunities of this scheme and the learnings to be shared would be discussed.

Biography:

Hudson Nakamura is a Medical Specialist in Ophthalmology who specializes in Retina and Vitreous. He completed his medical education course School of Medicine at the Federal University of Goiás– UFG and Residency from the Base Hospital of the Federal District - Brasília - DF. Presently, he is a Member of American Academy of Ophthalmology, Brazilian Council of Ophthalmology, Canadian Society of Ophthalmology. He is also the Member of most prestigious society ARVO - The Association for Research in Vision and Ophthalmology, United States. Currently, he is working as a Professor in the Department of Retina and Vitreous Course of Medical Residency in Ophthalmology at the Bank of Goias Eye Foundation. He is also working as a Specialist in Vitreo-Retinal Disease Fellowship- University of Toronto Canada, a Specialist in Ophthalmology-University of Toronto Canada, and a Specialist in Vitreo-Retinal Disease Fellowship-Brazilian Center for Eye Surgery.

Abstract:

In the western hemisphere, ARMD (Age Related Macular Degeneration) is a very important cause of blindness, one that is evident with many distinct signs, such as Sub-Retinal Neo vascular Membrane (SRNM), elected for treatment. The treatment of SRNM, years ago, was solely relied upon laser photocoagulation of the membrane, reducing the risks of visual loss when treated promptly, without delay. Even in the macular (centervision area), laser used to be applied, the reason being to halt the process of membrane evolution. Through several studies such as MPS (Macular Photocoagulation Study), it was realised that within some months or years, the contrast sensitivity got better if the lesion was not treated. Even so, the patient ended up with bad vision acuity, due to the laser applied in that manner. Other treatments ensued with PDT (Photodynamic Therapy) and the use of verteporfin (visudyne), which was used together with PDT for sensitising the action of the drug through this non-thermal laser, shrinking the size and inhibiting the spreading of the membrane. Another option that did not last long was TTT (Transpupillary Thermotherapy), which does not use injected drugs, but only the non-thermal laser, and others, with Multicenter Studies throughout the world. Even surgical treatment was attempted like macular translocation, but no good results were obtained. Hence, these procedures were discontinued. Recent studies show how the involvement of pharmacology contributes to the success of the treatment. But the clinical research on pharmacology and the ARMD pathogenesis came up with the targeted cause of these lesions that is VEGF (Vascular Endothelial Growth Factor), responsible for the membrane formation and the process of angiogenesis ensued. So the development of pharmacological treatment for the membrane came to the most evolving drugs used in ophthalmology today, starting with pegaptanib sodium (Macugen) which is FDA approved, and other drugs under current studies despite being largely used since many years, such as bevacizumab (Avastin). Ranibizumab (Lucentis) is also largely used for the treatment of the disease, and Aflibercept (Eyelid) was approved for several diseases. These two drugs are also included in protocols for diseases different from ARMD. Finally, corticosteroids are far more developed these days for the treatment of ARMD, like triamcinolone acetate and Ozurdex (dexametasone implant), and Illuvien (fluocinolone acetone) which is being delivered as intravitreal implant different from the others mentioned which are delivered as injections. Other drugs are on the way of development and the treatment of the mentioned disease is based mainly on these drugs. This shows how developed this field became in the new era of ophthalmologic treatment of ARMD.

Biography:

Kishor K Chakraborty is a professional (MPharm PhD) having more than 29 years of diverse global exposure in various research and development assignments with Lederle (a division of American Cyanamid company), Hindustan Antibiotics, Concept Pharma (a farmer subsidiary of Lupin Pharma), and currently has been serving as Head – R&D in Riyadh Pharma (A leading pharmaceutical company in GCC). He has published & delivered over 20 manuscripts and lectures respectively.

Abstract:

During finished pharmaceutical product (FPP), manufacturing process development following QbD (Quality by Design) and in the race to be first to file product registration, a balance is needed between effective management of limited budgets and resources and obtaining and implementing sufficient process knowledge & understanding in a way that demonstrates process stability and predictability. This balance is necessary in order to manufacture products safely, reliably, and economically. This is particularly challenging for generic companies that are mostly or completely virtual, since their prevalent bias is towards both cost minimization and rapid development. A requirement common to all strategies, at all types of generic organizations, is adequate documentation and justification of the ultimate process used for late-stage development (exhibit batch) and commercial launch, in order to demonstrate that quality by design (QbD) has been implemented. Th ere is an inherent tension between the need to move as rapidly as possible (first to file), and the need to accumulate sufficient knowledge along the way that can be leveraged at each successive stage of development. This present study explored these competing priorities and attempted to address the conceptual uncoupling of expediency and QbD vis proposes several strategies (i.e. Self- auditing, outsourcing, concurrent/overlapping e-submission & automated continuous conformity monitoring and cybernetics correction of the process deviations etc.) for how these seemingly contradictory needs may be accommodated in a single, integrated (matrixes) approach. Three critical aspects of this approach are quicker development of process understanding, a smarter strategy of experimentation (screening, characterization, and optimization) that collects the right data in the right amount at the right time and a process management system that faster integrates process control and process improvement. It is concluded, there is definitely link of high probable regulatory conformance satisfaction/ confidence level to likelihood of success in accelerating regulatory speed of approval of submission.

Biography:

Abstract:

Description: Pharmacogenomics, also known as personalized medicine, has received increased attention in recent years. But what is pharmacogenomics and is it really a new idea? Pharmacogenomic ideas and technologies have the potential to impact numerous areas of medicine including clinical trials, new product development & manufacturing and the practice of medicine. And with the recent deaths due to fungal meningitis from the New England Compounding Center, what will be the ramifications not just on traditional compounding, but more importantly on pharmaceutical and medical device manufactures now and in the future. Appreciating what the future may hold will better prepare us for what has yet to come. During this presentation, participants will be exposed to a broad mix of pharmacogenomic ideas and applications currently on the market, under development, on the drawing board and beyond. See ‘Pharmacogenomics may change the way medicine is practiced’ for more. Goal(s): “Simply put… the goal of this presentation is to get people to think! To purposely provoke them, to look at the way we develop and manufacture medical products today and ask does it make sense? Regrettably, far too few seem to be willing to do this. Many seem to be content with the status quo; to continue to do what we have been doing in the past for no other reason than that’s the way we have done it, OR that’s the way others do it, or worse, that’s what is required. Using many real case studies, I try to teach people how to think not what to think. This is all too uncommon in medical technology. My mantra is simple: if you always do what you always did, you’ll always get what you always got. Alternatively, if you always think the way you always thought, you will also always get what you always got. It seems this happens all the time. The problem is if everyone thought this way, we would still be living in caves in medical development, in medicine in general and in life, we must always question the status quo. We can and should do better! Th at’s the takeaway from this workshop.” – Dr. Michael Drues.

Biography:

Mishal A Altamimi is a pharmacist graduate from the college of pharmacy King Saud University Riyadh Saudi Arabia in 2002 and got a master degree in health administration from King Saud University Riyadh Saudi Arabia in 2007 he joined the SFDA in 2006. He worked in several positions including the pharmaceutical license department and now is the director of the Department of the cosmetics department.Cosmetics regulations in Saudi Arabia

Abstract:

Pharmaceuticals, cosmetics, medical device and food were scattered between different government organizations before the establishments of the Saudi Food and Drug Authority (SFDA) in 2004. It took the SFDA about ten years to take all the responsibility in these years the SFDA built the infra-structure and invest heavily in the training and education by sending its young generation employee to the best universities in the west. Also during this time a lot of laws, regulations and guidelines based on best international practices were written and went through the approval processes. One of these laws is the cosmetics law which is in the final stages of the approval processes. The cosmetics law will be the first in the region, and Saudi Arabia will be the first to have a comprehensive law covering all aspects of cosmetics regulations, to cover the huge market of cosmetic products which is around 2 billion dollar; some of these products are manufactured locally and some are imported from all over the world, with a market open the necessity for a good regulatory system. a system that will control the cosmetic product at the points of entry (borders) as well as in the local manufacturers until it reaches the consumer by establishing a good notification system, cosmovigilance, developing cosmetic products safety guidelines and establishing good labs that will analyze the product to be sure it fits the standards and no hazardous material been used. In this presentation all aspects of cosmetic regulations in Saudi Arabia will be discussed.

Biography:

Dr. Jianjie Wang is an Assistant Professor in Department of Biomedical Sciences at Missouri State University, USA

Abstract:

Extracellular nucleotides and their cell surface receptors have emerged as key players in inflammation. Hyperpermeability is a hallmark of inflammation and leads to vascular leak resulting in pulmonary edema that often occurs in the intensive care unit (ICU). To date, there is no specific pharmaceutical treatment for edema by a strategy of anti-vascular leakage except expulsion of excess fluid in the form of urine by diuretic drugs. Recently emerging evidence demonstrates nucleotide P2Y2 receptors play important roles in vascular inflammation, including arterial neointimal hyperplasia, increased vascular cell adhesion molecule-1 expression. My in vivo studies revealed that nucleotide P2Y2 receptor activation induced transient 5-fold increase in venular permeability to albumin (Ps) from baseline in wild type (WT) mice, but not in P2Y2 R knockout (P2Y2 R KO) mice. The P2Y2 R signaling-dependent hyperpermeability was mediated by focal adhesion kinase (FAK). Activation P2Y2 R induced phosphorylation of FAK at tyrosine-397 in origin-matched primary cultured murine microvascular endothelial cells. VE-cadherin, a key molecule of the adherens junction present at endothelial cell-cell junctions, increased activity in response to P2Y2 R agonist, UTP, implicating the paracellular pathway contributing to hyperpermeability. Taken together, the findings support nucleotide P2Y2 R play important role in microvascular leak.

Biography:

Elizabeth Alves Fernandes is a Senior Associate in the Sao Paulo office of Tauil & Chequer Advogados in association with Mayer Brown LLP. For more than ten years, she has focused on providing legal assistance for pharmaceutical companies and clients from the medical devices, cosmetics, food, beverages, sanitizing products and human and animal health sectors. She holds PhD and Master degrees in Law from the University of São Paulo and a Master Degree from the European College. She is an author of books, chapters and articles on health-regulatory law and environmental law. She speaks at seminars on health-regulatory matters.

Abstract:

Productive Partnerships for Development (“PDPs”) of priority drugs are in the center of the discussions about the supply of drugs for the Brazilian public market. Under PDPs, public laboratories receive technology for priority drugs which have been developed by private pharmaceutical companies. The public laboratory then onsells the drugs to the Brazilian government. The purpose is that the public laboratories are able to supply the public sector in the long term and the PDP ultimately equips it with the technology (including the access to cell banks) and skills to do so. However, until the technology transfer has occurred – which demands a certain maturity - the public laboratory buys the product manufactured by the private company.

Biography:

Kamilah Rashid is a Doctorate of Pharmacy Degree candidate at Mercer University College of Pharmacy. She completed her Bachelor of Science degree in chemistry from Spelman College and a post-baccalaureate biomedical research program at Arizona State University.

Abstract:

Eighty-seven percent of adults use the internet and 90 percent have cell phones, with 78 percent using smartphones. Over the years, the rising trend of people with access to the internet and those who are smartphone users aided in the exponential development of mobile applications. In this digital age, there is a constant demand for convenient access to databases, particularly those that are health, drug or regulatory-related, in part due to healthcare concerns in the US. Currently, there exist a vast number of mobile applications that fall within these categories. The majority of health related applications on the Android and Apple markets focus on the diagnosis of diseases and other conditions, cures for diseases, treatment or prevention of diseases, causing them to be defined as mobile medical devices according to the FDA standards. Additionally, the FDA supports the rapid provision of regulatory information to patients. In today’s competitive and highly regulated healthcare environment, it is essential to develop creative and innovative health related applications to address regulatory issues. Currently, there are no US mobile applications that provide a comprehensive review in addition to continuous updates on all facets of regulatory affairs. The development of a regulatory affairs mobile application that offers healthcare professionals and patients with critical information regarding regulation of clinical trials, safety issues, marketing approval applications, post-marketing activities and more, would help bridge the knowledge gap between patients, healthcare providers, and pharmaceutical companies.

Biography:

Ricardo Ibarra-Cabrera is a Biotechnology Engineer from the Instituto Tecnolgico de Estudios Superiores de Monterrey, Mexico City Campus, and is a candidate for MSc in Innovation and Business Development from the same University. He has experience in pharmaceutical clinical trials and consulting services to Total Quality Management for clinical studies units. He is the Director of INBIOXICA, S.A. de C.V., a Mexican R&D and innovation consulting firm. His area of interest includes biopharmaceuticals and biobased products.

Abstract:

In the last ten years, the Mexican healthcare sector has gone through several big transformations. The development and implementation of new initiatives have changed the sector’s dynamics. For instance, universal health coverage in the country requires medical attention and provision of medicines to more than 15 million people who did not have access to them before. In this regard, the Federal Commission for the Protection of Sanitary Risks (COFEPRIS) has taken several measures such as abbreviating the approval pathway for generics, derogating the local plant rule for drug production, phasing out copy drugs that are not bioequivalent, and establishing a clear regulatory framework for biopharmaceuticals and biosimilars. Moreover, for the sake of increasing expenditure on R&D activities, new funding programs have emerged from different Mexican Institutions that stimulate the development of the biotech and biomedical sectors. Consequently, the fastest healthcare spending growth in the Latin American region will be in Mexico, at more than 10 percent a year. Therefore, new challenges and business opportunities have arisen for the healthcare and pharmaceutical industries in the country. The upcoming years are a milestone for this sector to flourish and succeed in improving people’s quality of life.

Biography:

Dr. Amy Peterson is QA Manager at Quality Systems, USA

Abstract:

Lessons Learned from North America Commercial Nuclear: Design the Most Robust & Effective Deviation/CAPA System within the Pharmaceutical Industry, Predict but Monitor Effective Corrective Actions; Implement Quality Near Misses to Generate Preventive Actions, Encompass Adverse Human Error Trends; Utilize Error Prevention Techniques, Achieve Adherence to Standard Operation Procedures (SOP); Learn KEY Role of Human Factoring Processes and Instructions, Manage Human Error in Quality Systems to prevent events

Biography:

Dr. Martha Rumore is a Fellow of the American Pharmacists Association and Associate Professor at Touro College of Pharmacy where she teaches Pharmaceutical Law and Drug Information. She also taught Drug Regulatory Affairs and Food, Drug Cosmetic Law at Long Island University College of Pharmacy.

Abstract:

FDA’s proposed rule to amend the regulations would allow generic manufacturers to change their products’ labeling to reflect newly acquired safety information in advance of FDA’s review of the change; i.e. changes-being-effected (CBE-0) procedures. Currently, ANDA holders may not use the CBE-0 process to unilaterally change ANDA labeling in a manner that differs from the Reference Listed Drug (RLD). FDA’s proposal comes about, in part, because of two recent U.S. Supreme Court decisions. In 2011, in Pliva Inc. v. Mensing the Court held that injured plaintiffs’ state-law failure to warn claims against generic manufacturers are pre-empted under federal law. In 2013, in Mut. Pharm Co. Inc. v. Bartlettthe Court held that injured plaintiffs’ state-law design defect claims against generic manufacturers that turn on the adequacy of a drug’s warnings are also preempted by federal law. In the aftermath of these two decisions, consumers injured by generic drugs are left without recourse. Proponents of FDA’s proposed ruleargue that it will provide an avenue to file failure-to-warn tort claims against generic manufacturers and encouraging them to establish extensive drug safety systems to protect the public while creating parity among application holders. Opponents argue that the proposed rule violates FDAs statutory mandate, would increase generic drug prices (and potential shortages), and rather than promoting safety would lead to confusion when labeling for a generic version of a medication will not be the same as labeling for the underlying brand-name drug. The proposed rule would create a regulatory framework whereby multiple different warnings can simultaneously exist in the marketplace for multiple generic versions of a drug. Opponents also argue the billions of dollars that will be diverted to the legal system by consumer plaintiffs could better be devoted to healthcare improvements. Other advocate that in as much as an absence of evidence exists to indicate that current authority of brand manufacturers to make temporary labeling changes upon submission of a CBE-0 supplement has led to improved patient safety, the current policy should be re-evaluated. FDA may proceed with a final proposed rule, which generic manufacturers have vowed to legally challenge or legislation may be proposed.

Biography:

Dr. Frestedt has more than 30 years experience in clinical research and business leadership. Frestedt is currently the President / CEO for Frestedt Incorporated, a consulting group of over 50 experts providing services in the broad areas of clinical trial development and execution, as well as US and international regulatory compliance, medical writing and management of corporate quality systems. Dr. Frestedt has experience running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally. Frestedt Incorporated is a novel virtual network of highly skilled staff meeting specific needs for large and small projects.

Abstract:

FDA issued draft guidance about “low risk” “general wellness” products in January 2015 and stated the CDRH “does not intend to examine low risk general wellness products to determine whether they are devices...” This talk will review these types of products and explain the process to determine if the product is low risk and about general wellness to fit into this category.

Biography:

Lucimar Filot da Silva Brum has completed her PhD in Biological Sciences (Biochemistry) from the Federal University of Rio Grande do Sul (1999). She is an Associate Professor at Lutheran University of Brazil, working in the Postgraduate Genetics and Applied Toxicology Program, Postgraduate Program in Cellular and Molecular Biology Applied to Health, Pharmacy Course, and Bachelor of Aesthetics and Superior Technology Course Beauty and Cosmetic. Her research areas include investigation of efficacy and safety of drugs, natural products and bioactive substances. She is the Teaching Coordinator at ULBRA Canoas.

Abstract:

Skin aging characterized by sagging, blemishes and wrinkles, resulting from tissue structural changes, especially due to decrease in assets fibroblasts and consequent decrease in elasticity and collagen synthesis. It is a high demand for active compounds that may be incorporated into cosmetics for preventing and slowing the signs of skin aging. Growth factors or analogous substances such as, Carboxyethyl Gamma Aminobutyric Acid (CEGABA), a neuromodulator derived from polyamines appears to be a promising substance in the rejuvenation strategies. However, there are no studies proving its effectiveness and safety. In this context, the present study was to evaluate the effect of CEGABA in the proliferation and migration of fibroblasts in vitro. We used a fibroblast cell line NIH 3T3, which was exposed to CEGABA compound and the analysis of cell proliferation was performed by inoculating the cells in plaques and assessment of cell migration in vitro, we used the scratch wound assay. Cytotoxicity assessed using the MTT colorimetric assay, and assessing the genotoxicity performed using the alkaline comet assay version. Our results indicated that the compound CEGABA stimulated cell proliferation and migration of fibroblasts and did not show cytotoxic and genotoxic effects, suggesting that the use of CEGABA in cosmeceuticals is safe and can be used as adjuvant in therapeutic against aging.

Biography:

Dr. Cleanthes Israilides is director at National Agricultural Research Foundation, Greece

Abstract:

Beta-glucans, especially beta 1,3-linked and beta 1,6-linked -glucans, from eukaryotic organisms particularly medicinal edible mushrooms can be incorporated into various foods creating novel “functional foods” with many health promoting benefits beyond their nutritional value. Medicinal mushrooms have long been valued for their properties as immune system boosters and modulators, as antioxidants, as blood glucose regulators, reducing cholesterol and blood lipids as well as having many more therapeutic and recuperative properties reducing the risk of chronic diseases and promoting general health. The health benefits of mushrooms are attributed to many bioactive compounds among which the most valued and well studied ones are the β-glucans. These can be isolated and incorporated to various foods and food products enhancing their nutritive value and creating novel “functional foods”.

Biography:

Maria Soledad Lopez Distor is a Registered Chemist and has completed her Bachelor of Science Degree in Chemistry from the University of the Philippines, Los Banos and Post-graduate studies in Management major in Public Administration from the Laguna College of Business and Arts. She is currently connected with the Philippine Accreditation Bureau as Technical Expert/Assessor in the field of Chemical Testing for ISO 17025 Laboratory Accreditation. She is also a part-time faculty of the Systems Technology Institute handling lectures on Chemistry, Physics and Biology. She is a former Senior Food Drug Regulation Officer of the Food and Drug Administration Philippines, a regulatory agency mandated to ensure the safety, quality and efficacy of pharmaceuticals, processed foods, cosmetics, household hazardous substances and medical devices. She was assigned at the ASEAN Reference Standards-Central Laboratory, tasked to establish and develop pharmaceutical Reference Standards in collaboration with other national and regional regulatory laboratories of ASEAN member states. She has a number of oral presentations on conventions and symposiums, both local and international invitations.

Abstract:

ASEAN's development, though gradual and slow, has consistently demonstrated an uphill shift from a focus on regional peace and stability to closer economic integration. The ultimate goal is to achieve an integrated ASEAN community by the year 2015 with a common regional identity. Efforts toward ASEAN harmonization were initiated through the ASEAN Consultative Committee for Standards and Quality (ACCSQ). Hence, it was agreed that a Product Working Group on Pharmaceuticals, now referred to as Pharmaceuticals – Product Working Group (P-PWG) be set up. The ASEAN’s PPWG is contributing to the ASEAN Economic Community 2015 vision by establishing the pharmaceutical harmonization scheme. The goal is to create common regulations for pharmaceuticals in the region, reduce barriers to trade and to ensure that pharmaceutical products penetrating the ASEAN markets show sufficient safety, quality and efficacy. With growing inter-dependence among nations as well as expanding global opportunities in pharmaceutical trade, efforts toward developing a new strategic partnership in pharmaceutical regulatory harmonization has recently become an important agenda of ASEAN. Inspired by these concerted efforts and taking into consideration the current international best practices of expediting product registration process, the ACCSQ – PPWG has thus taken a harmonized approach to facilitate the availability and accessibility of quality, safe and efficacious products, in the interest of patient and public health. And one of the milestones in the harmonized approach is the establishment of pharmaceutical reference standards. The project on the Production of ASEAN Reference Standards (ARS) was initiated in 1980 under the Technical Cooperation among ASEAN countries on Pharmaceuticals, and was supported by UNDP and WHO with Thailand as the coordinator. The objective of the project is to enable the ASEAN countries to produce pharmaceutical reference standards for utilization within the region. Through thirty three (33) years of cooperation among member countries, the overall implementation of the activities in terms of manpower training and the production of ARS were considered satisfactory. The outcome of the project has benefited all participating countries.

Biography:

Marcio Raposo de Almeida has completed his specialization in public health surveillance and health by the Office of Science, Technology and Industrial Quality - ICTQ and his law degree from Universidade Candido Mendes. He is the director of MRA Consulting Business, having acquired extensive experience in the regulatory and legal area, especially when it comes to ANVISA.

Abstract:

One of the biggest problems that businesses face when it comes to ANVISA is the length of its claims. In this situation, which does not include the appeals process in case of refusal, the Company has invested in technology, marketing, research and development, among other things, cannot wait that long for a final decision on its application for registration. The Law 6.360/76, specifically in § 3, the Art. 12 provide that the registration will be granted no later than ninety (90) days. (very different time those presented in the table above). The judiciary is deferring injunctions that ANVISA review the claims of the Company and provides deadlines for compliance. Indeed, it is not uncommon to see in the Official Gazette records are granted to have their claims have been reviewed by court order. Importantly, the judge hardly determines that ANVISA grant a record, but expedite the examination of a resource, for example, is common. You cannot generalize the deadlines, because everything depends on the documentation of the quality, complexity, among other factors involving each specific case. The international inspections were also the subject of injunctions in 2014 and today the Inspection Management is doing everything to compliance with judicial decisions and those cases that preferred to wait in line. The goal here is not to encourage the companies to seek the judiciary to solve all your problems, but expose the current panorama of the justiciability of matters involving ANVISA. Solve administratively is always the best option, but to wait years to see their drug application, for example, be analyzed, is too much for one company that has invested and does not see the return with the brevity that the law requires. Finally, ANVISA is doing everything to improve these analyzes, either by creating or modifying regulations its internal structure. So it is important to follow the meetings of the Board of Directors, in addition to the technical meetings with ANVISA make associations and syndicate.

Biography:

Ting-Chao Chou received MS in Pharmacology from National Taiwan University, and PhD from Yale University, and Postdoctoral Fellowship at Johns Hopkins University, School of Medicine. He joined the Memorial Sloan-Kettering Cancer Center (MSKCC) and became a Member in 1988, and was a Professor of Pharmacology at Cornell University, Graduate School of Medical Sciences during 1988-2000. He was the Director of Preclinical Pharmacology Core at MSKCC, where he retired on January 06, 2013. He is the Founder of PD Science, LLC., USA. He published 273 articles that have been cited by 16,421 papers in 620 bio-medical journals worldwide including Thomson Reuters Web of Science and Google Scholar Citations with 22,336 citations, h-index 65 and 38 U.S. Patents. He introduced the “Unified Theory of the Median- Effect Equation of the Mass-Action Law” in 1976 for single drug, and with Prof. Paul Talalay (JHU) in 1984, created the “Combination Index Theorem” for multiple drug dynamics. His dynamics equations and software have been utilized to advance Econo-Green Bio-Research.

Abstract:

The triangular bi-directional dynamic equilibrium relationships among Research, Development and regulation set the reality framework of our nation and the world for scientific innovation, developmental status and legal security. Basic bio-science research is fundamental but is heavily influenced by NIH, foundations, peer review, and scientific trend. The eventual purpose in research is to improve knowledge and to produce something useful and beneficial to our life. These lead to the emergency of applied sciences such as those in pharmaceutical industry. To ensure the advancement and to constrain the behavioral selfishness and greed and to safeguard security, we have regulatory agencies such as FDA and USPTO to enforce law and order. The scientific community, from time to time, need to review and reform in the reverse directions in the triangular equilibrium dynamics, based on the sound and rigorous scientific basis. This is the main objective of my talk at 5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs-2015. We hope to have an open forum to exchange ideas and to formulate the scientific consensus for our better tomorrow.

Biography:

Juhi Tiwari is an MPharm in pharmacology from Jayoti Vidya Peeth Womens’ University, Jaipur, India. She has attended National and International conferences and has published research paper on antipyretic effect.

Abstract:

Phytomedicine are the staple of medical treatment in many developing countries. According to article Phytomedicine in clinical trials, “Phytomedicine has become an important alternative treatment option for patient in western world, as they seek to be treated in a holistic and natural way aft er an unconventional response to conventional drugs. Various plant products have been tested and found to be possessed with anti urolithiatic activity. The present study was designed to investigate the anti urolithiatic activity of extracts of the roots of Ricinus communis. Ricinus communis has anti inflammatory activity, antidiabetic and hepato protective and CNS stimulant actions. To assess effect of hydroalcoholic and pet ether extracts of Ricinus communis on Ethylene glycol and Ammonium chloride induced urolithiasis, both extracts was dissolved in hydroalcoholic and DMSO solution for oral administration at a dose of 200 mg/kg bwt and 400 mg/kg bwt. The standard cystone at 750mg/kg bwt significantly reduced the induced urolithiasis. Result: Result obtained for standard drug treated and hydroalcoholic extract and pet ether extract were compared with control (0.75% EG and 1% AC in drinking water) group and signifi cant reduction in size and number of stone was observed. Conclusion: Th us from present investigation, it can be concluded that hydro alcoholic extract of roots of Ricinus communis possess signifi cant anti urolithiatic activity.

Biography:

Mariam Aslam has 10 years of regulatory affairs experience. Her current role is working as a Senior Consultant at PAREXEL International, UK. Her experience includes working with conventional medicines, herbal medicines, cosmetics and medical devices regulations. She studied a degree in Chemistry at the Manchester Metropolitan University in the UK. She also attended and participated as a Moderator and Speaker in the OMICS Group Inc., at the 4th 5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs (8-10 September 2014) in Raleigh, NC, USA. Her speech was on “Herbal Medicines: Product License to Traditional Herbal Registration in the UK”.

Abstract:

Regulatory Intelligence (RI) is likely to have been practiced in some way or other from when regulations first came into existence. In the recent years, RI has become more of a phenomenon in the pharmaceutical regulatory sector. Although the brilliance of this concept is still evolving, two definitions have been created for RI; one from the Drug Information Association’s Regulatory Intelligence Network Group (DIA RING) and the EU Regulatory Intelligence Group (EU RING). The DIA RING definition is: ‘The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future regulations, guidance, policy, and legislation. The EU RING definition is: ‘Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities–to the regulatory strategy. The process is driven by business needs and linked to decisions and actions.’ However you interpret these definitions, RI key aspect is applying the acquired knowledge from drug discovery to post approval. A vast amount of years and cost is invested in getting the drug on the market. Then when it gets to the market, what happens next? This is when the importance of RI ensures the best regulatory strategy so that your drug’s safety, quality and efficacy are maintained during its lifecycle.

Biography:

Avong is a public health pharmacist, implementer of public health initiatives and a certified operational researcher. He holds a Bachelor of Pharmacy (BPharm) from the Ahmadu Bello University, Zaria, Nigeria and a Master of Public Health (MPH) from the University of the Western Cape, South Africa. He is also in the process of pursuing a PhD in Pharmacovigilance and Pharmaco-epidemiology. In 2009, he inspired the setting- up of the spontaneous reporting system (SRS) in two public health programs (ART and MDRTB) and supervised the collection and analysis of over 2000 individual case reports (ICRs) from these programs. He has published papers in ADRs and adherence to anti-retroviral therapy (ART). Furthermore, he has peer-reviewed many manuscripts and participated in several international researches like the START study, while contributing to the development of the current “Integrated National Guidelines for HIV Prevention Treatment and Care in Nigeria”. As the head of the Pharmacy Division and Associate Director with the Institute of Human Virology, Nigeria (IHVN) – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care, he oversees the delivery of pharmaceutical care service in all the grants. He served as the liaison officer between the Martindale Pharmaceutical Limited, UK and the Federal Government of Nigeria for the importation of Narcotics for the public sector in 2003/2004. His current interest is promoting pharmacovigilance in public health programs.

Abstract:

Adverse drug reactions (ADRs) were the 4th to 6th cause of death in the United States of America (USA) in 1994. In other countries, ADRs have increased the cost of providing health care and are complicating the management of co-morbidities like HIV/AIDS and TB. Thus, in many western countries, pharmacovigilance (PV) has been instituted as an effective public health measure to protect the general population from the harmful consequences of ADRs. In Sweden, France and Italy, reporting of ADRs is compulsory. In the USA and more recently in some other countries, patients can also report directly to the spontaneous reporting system (SRS). In developing and resource limited countries, the PV systems are emerging; in recent times, the factors that have promoted the development and strengthening of pharmacovigilance in the developed countries are emerging in the developing countries. For instance, having a national policy on PV and a strong governmental commitment, a robust drug manufacturing sector, a vibrant health system with the potential to track and recall suspected drugs from the market, a strong central regulatory system working in collaboration with the global pharmacovigilance center and an enlightened work force, are predictors of an effective PV system. In this presentation, we shall highlight the emergence of these factors using the case of Nigeria to demonstrate the prospects of PV in resources limited countries. We shall also unveil the challenges that have to be addressed in order to strengthen PV in poor countries.

Biography:

Demet Sag is director of translational genomics at symmetric computing, ClearRoadmap, USA.

Abstract:

Carver Global Health Group LLC (CGHG) is a privately owned company that builds and distributes ClearRoadmap, a cloud based data analytics platform to automate the manual, time consuming mHealth and medical device regulatory and reimbursement due diligence process. All new medical devices are required to complete this step. ClearRoadmap improves data accuracy and reduces time to completion from days or weeks to minutes. CGHG’s innovative approach provides the potential to transform how mHealth and medical devices are developed and brought to market. Solution: ClearRoadmap applies Best Known IT Practices from Big Data to automate these highly manual processes. Benefits include: improving data accuracy and relevance for related mHealth and medical devices; speeding access to relevant data both initially and through ongoing market activities. ClearRoadmap provides value to a range of healthcare industry players. ClearRoadmap flexible subscritption allows users to try each mondule individually, leverage savings with package rates, and an enterprise seat bring value to those who visit : The single Search interface across all datasets is accessible globally on tablets, laptops and desktops. The detailed product information is displayed in a side-by-side Comparison, for market evaluation. Details can be downloaded into Reports with the search criteria documented, and hyperlinks to original document sources. Users can save customized searches as an Alert to receive notifications when changes or new information becomes available. Users can plan their Idea to Market using step-by-step Pathways which consolidates state legislations, federal regulations, reimbursement policies, technical standards, and business strategy with Best Practices and Helpful Hints.

Biography:

Rajiv Mahendru completed Post-Graduate Degree in Obstetrics and Gynaecology from Himachal Pradesh University at the age of 29 years and became one of the youngest Professors. Presently, he is the Head of the Department in the only second women medical college of India. He has 41 publications in reputed journals and is the recipient of a prestigious award for excellence in medical field. He is appointed as the Chief-Editor of the special issue of an international journal of repute and has numerous presentations to his credit at international arena as an invited guest speaker. He is the member of editorial board of international journals, academic board of many universities, member of recruitment for medical teachers, and assessor for establishing Medical colleges. He has chaired numerous sessions in the national and international conferences.

Abstract:

Objective: For assessment of effects of supplementation of antioxidant lycopene in antenatal cases considered high risk candidates for pregnancy induced hypertension (P.I.H) and/or fetal growth restriction. Materials & Methods: A pilot study comprising 107 pregnant women between 13 and 28 gestational weeks with factors considered high risk for developing pre-eclampsia were considered and randomly allocated into two groups: I (n=55) and II (n=52), with orwithout lycopene supplementation, respectively. Lycopene in a dose of 4 mg once daily starting from the date of entry was given to the antenatal subjects of the study group (Group-I) and were instructed to continue the drug regularly until delivery. Women of the other group (Group-II) were not provided with lycopene supplementation. Main observation measures considered were whether there was development of preeclampsia and its severity, period of gestation at delivery, mode of delivery, fetal weight and perinatal outcome as regards to admission to neonatal intensive care unit and neonatal death. Observations: There were no signicant differences in development of preeclampsia in both the groups but severity was more in the group-II where patients did not receive lycopene. Significant adverse finding noticed, having no mention in the literature earlier, was: one case of eclampsia. Women in the lycopene supplementation group had not only signicantly lesser incidence of growth restricted babies but also signicantly healthier babies and had a signicantly better perinatal outcome compared to women in non- supplementedgroup. Conclusion: Supplementation of lycopene although does not decrease the incidence of preeclampsia in high risk women but may help in reducing its severity and there is reduced incidence of intrauterine growth restriction with better prenatal outcome.

Biography:

Bellaje R is Faculty of Sciences in Ibn Tofail University at Kenitra, Morocco.

Abstract:

Objectives: In Morocco the large number of cosmetic products is sold freely without control or registration. Some of these products can lead adverse reaction or poisoning in case of misuse or voluntary ingestion. The lack of knowledge of the composition of these products make therapeutic management in case of poisoning very difficult and sometimes causes unnecessary health spending even if these poisoning are oft en benign. The objective of this study is to establish the epidemiological profile of a poisoning by lightening creams collected at the Moroccan Poison Control and Pharmacovigilance center. Methods: This is a retrospective study of poisoning case by lightening creams collected at the Moroccan Poison Control and Pharmacovigilance Center between 1987 and 2011. Results: During the study period, 95 cases were collected. The mean age is 20 years±1.4 [1-70 ans], and the F/M sex ratio is 1.73. In 90 (95%) cases, the route of poisoning was oral. The suicide attempts represent 33% of cases. Women are oft en voluntarily intoxicated. However, men were concerned by involuntary intoxication (p=0.003). Eighty three cases were urban (87%) and 90 cases occurred at home (95%). The digestive disorders were found in 68 cases associated or not with a neurological disorders (33 cases), cardiovascular disorders (14 cases), and respiratory distress (6 cases). The evolution was favorable in all cases. Conclusions: The implementation of the new law recording to the registration of cosmetic products in the ministry of health before marketing will ensure certainly a better orientation of the poisoning case management and improve the patient safety.

Biography:

Sara Hegazi is Quality & Regulatory professional in medical devices in Philips Healthcare covering Middle East &Turkey (MENA region), her pervious experiences as regulatory expert in pharmaceutical industry. She is a member of Mecomed, and she has experience in managing registration requirements in 14 countries in Middle East. She has directed Post-Market Surveillance/Vigilance served as compliance officer, throughout her career. She has also had responsibility for Quality Assurance, Audit Management, Healthcare Compliance, and Clinical functions.

Abstract:

Middle East region is one of fastest growing medical devices market in the world, providing signifi cant opportunities for medical devices development and marketing. At the same time, the Middle East region is one of the most vibrant areas in the world and presents a major challenge: Challenges facing the healthcare industry throughout the MENA region as populations grow and life expectancy increases. A key issue in the region remains the growing number of chronic conditions and diseases such as diabetes, obesity and heart disease. The medical infrastructure must also improve and expand; healthcare authorities in the MENA region are playing a vital role to develop & improve advanced regulatory guidelines to adapt to new challenges, as well leading educating and training local workforces, which can only be achieved by partnering with international companies. It is estimated the GCC healthcare market is to grow 11% per annum to $43 billion by 2015 and on to $60 billion by 2025. The UK healthcare system is highly regarded throughout the MENA region and opportunities are available across all aspects of the healthcare sector. The challenges are different for each country. Challenges are still remaining, which include understanding the local requirements, communicating effectively with the authorities, managing the time to receive the approvals, and providing solutions for the unexpected problems. A successful regulatory strategy requires a strong understanding of the regulations, guidelines, and effective communications with internal stakeholders and with the health authorities & take advantage of the opportunities to expand their products in this dynamic part of the world.

Biography:

Bellaje R is Faculty of Sciences in Ibn Tofail University at Kenitra, Morocco.

Abstract:

To assess the extent and severity of poisoning by hydrogen peroxide dye hair used as the Moroccan population, a retrospective epidemiological study of all cases of poisoning reported, collected by the Moroccan poison control and pharmacovigilance center, between 1987 and 2011 was realized. The center has received 43 reports. The mean age was 18±2 years [0.1-50 years] and the female/male ratio was 2. The majority of cases of poisoning were occurred in the urban area (35 cases) and at home (31 cases).The digestive disorders were found in 17 cases, associated or not with a neurological disorders (2 cases), cardiovascular disorders (1 case) and skin disorders (1 case). Twenty patients were referred to the emergency care unit. Symptomatic treatment was ordered in 26 cases and gastrointestinal decontamination in 11 cases. The evolution was favorable in all cases.

Biography:

Solomon Getnet Meshesha has completed his Bachelor of pharmacy from Addis Ababa University in 2008. He has been working in Addis Ababa City Administration health bureau as a director of pharmaceutical service since October 2008. He is a member of Ethiopian Pharmaceutical Association. Now he is a postgraduate student in pharmacoepidemiology and social pharmacy at Addis Ababa University.

Abstract:

Issues related to the quality of medicines are becoming an increasing global concern especially in developing countries. Achieving a high level of quality requires effective medicine legislation and regulation, a competent medicines regulatory authority, good clinical and manufacturing practices with adequate medicines, quality assurance programs and medicines, quality control systems and appropriate medicines information. A qualitative study design was used to obtain primary and secondary information through interviewing key informants and reviewing all available relevant documents from the Addis Ababa city administration medicine regulatory and control authority. Addis Abba medicine regulatory authority is an independent organization whose top management committed to implement quality management and data on licensed and resisted health facilities and professionals are up to date but the authority has no policy on confidentiality and code of conduct for staff s, guideline to ensure requirements on quality, safety and efficacy of drugs and also mechanism to trace any counterfeit and substandard drugs. It has no any scientific body (laboratories) to advise the organization on scientific issues. The regulatory authority was an independent authority established to ensure food safety and quality, efficacy and proper use of medicines, competence and ethics of health professionals and standards of health institutions through licensing, registration and regulations against the set standards. The authority has to keep those findings as strength of the organization and much has to be done to meet the authority’s goals and objectives.

Biography:

Varley Dias Sousa is a Pharmacist (2003), post-graduated on health surveillance (2007) and international health systems (2006), and has completed his MSc (2010). Currently he is performing PhD studies at the University of Brasilia. He is a senior Auditor on Brazilian Health Surveillance (ANVISA) since 2005, been certified in Good Manufacturing Practices (inspecting international facilities in almost 10 different countries) and Good Clinical and Laboratory Practices (Inspecting more 30 international CROs). He has evaluated more than 150 bioavailability and bioequivalence (BA/BE) studies and more than 150 Medicine Applications. Also, he is member of the commission in charge of confidentiality classification on Medicine Dossier. Dâmaris Silveira is a Pharmacist (1986), with PhD in Natural Product Chemistry (1999). Currently she is Associate Professor at the University of Brasilia, and coordinator of Laboratory of Quality Control as well as of the Pharmaceuticals – Regulation and Public Policies research group.

Abstract:

Backgrounds: Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the building process of an open government is still fragile and fragmented on Health Regulatory Agencies (HRA) even on Regional Reference Authorities (RRA). Purpose: This paper assesses the transparency status of RRA, focusing on some medicine life-cycle documents (Medicine Dossier, Clinical Trial Report, and Inspection report), as tools for strengthening health systems. Methods: Through a qualitative and descriptive evaluation of regulatory transparency on RRA, it was portrayed in two different branches: information public disclosure and inter-agency data and work sharing. Results: The risk benefits of information public disclosure were assessed considering the involvement and roles of multi-stakeholders (healthcare professionals, regulators, industry, community, and academics) bearing in mind the protection of commercially and personally confidential data. Inter-agency data and work sharing were inserted in the context of harmonization and co-operation projects that focus on regulatory convergence. Conclusions: Technical and practical engagements are proposed to improve and strengthen health systems in the region of the Americas through establishment of an openness directive over pharmaceutical regulatory environment. To successfully address these challenges is crucial that regional leadershipssteer and support collaborative regional alliances toward the development and establishment of a trustful regulatory environment as well as a sustainable public health system in the Latin America and the Caribbean, using as reference international successful initiatives besides taking into account domestic characteristics and experiences of each single country.

Biography:

Shujie is Professor in Cancer Biology Research Center at Huazhong University of Science and Technology, China

Abstract:

Despite the encouraging development of a preventive vaccine for human papillomavirus (HPV), it cannot improve ongoing infections. Therefore, a new vaccine is urgently needed that can prevent and treat cervical cancer, and cure pre-cancerous lesions. In this study, we constructed two peptide-based vaccines. The first was a short-term, long-peptide (ST-LP) vaccine that simultaneously targeted three key carcinogenic epitopes (E5-E6-E7) on HPV16. We tested this vaccine in murine TC-1 cells infected with a recombinant adeno-associated virus (rAAV) fused with HPV16E5 DNA (rTC-1 cells), which served as a cell model; we also tested it in immune-competent mice loaded with rTC-1 cells, which served as an ectopic tumor model. The ST-LP injections resulted in strong, cell-mediated immunity, capable of attacking and eliminating abnormal antigen-bearing cells. Furthermore, to prolong immunogenic capability, we designed a unique rAAV that encoded the three predicted epitopes for a second, long-term, long-peptide (LT-LP) vaccine. Moreover, we used a new immune strategy of continuous re-injections, where three ST-LP injections were performed at one-week intervals (days 1, 8, 15), then one LT-LP injection was performed on day 120. Our in vitro and in vivo studies revealed that this strategy could boost the immune response to produce longer and stronger protection against target cells, and mice were thoroughly protected from tumor growth. Our results showed that priming the immune system with the ST-LP vaccine, followed by boosting the immune system with the LT-LP vaccine could generate a rapid, robust, durable cytotoxic T-lymphocyte response to HPV16-positive tumors.

Biography:

Mahmoud A S Morsi is Professor at Menoufia Medical School, Menoufia University, Egypt

Abstract:

Background: Diabetic neuropathy is the most common complication of diabetes mellitus. Oxidative stress is considered the key mechanism in the diabetic peripheral neuropathy (DPN) therefore; Silymarin may have a neuroprotective effect against the development of DPN via its anti-oxidant activity. Objectives: In this study, we investigate the possible effects of silymarin on DPN using STZ diabetic rat animal model. Methods: Forty-five male albino rats will be used along the study. Diabetes will be induced by a single Intra-peritoneal injection of Streptozotocin (STZ). All rats with BGL (blood glucose level) ≥250 mg/dl will be randomly assigned into 2 groups; Silymaringroup receiving 100 mg/kg/day of Silymarin by oral gavage for 2 months and Diabetic group receiving equal amount of saline for same duration. Behavioral tests will be done; including open field assessment of vertical and horizontal motor activities and tail immersion test for thermal hyperalgesia. At the end of the experiment, morphological, histopathological, biochemical and immunohistochemical changes of sciatic nerve will be examined. Results: This is an ongoing research and the experiment is still underway. We anticipate finding a possible neuroprotective effect of Silymarin in delaying the development of diabetic peripheral neuropathy in diabetic rats. Conclusions: The current work will add more evidence to the use of Silymarin as one of non-conventional medications of DPN. Silymarin can be used simultaneously as an adjuvant therapy to delay the onset of DPN in diabetic patients.

Biography:

Mouna Jrad from Laboratory of Plant Biotechnology Applied to Crop Improvement, Faculty of Science of Sfax. University of Sfax, Tunisia

Abstract:

An actinomycete strain was isolated from date palm leaves affected by brittle leaf disease (Deglet Nour, Tunisia). The strain was classified as a new bacterium, an endophytic strain. Identification was based primarily on the morphological characteristics. This strain was grown on a medium rich tryptic soy broth (TSB) with K2HPO4 (1 mM) and MgSO4, 7H2O (2 mM) at 28°C and neutral pH. It is a Gram-positive filamentous bacterium with broad spectrum antimicrobial activity. The optimum pH for the product was 7 to 7.4. The highest product yield was with glucose and tryptone at 1% (w/v) as carbon and nitrogen sources, respectively. Incubation between 25°C and 30°C for 24 hours was optimal for the bioactive metabolite(s) production. The product remained stable up to 50 hours. The bioactive metabolite(s) produced by endophytic bacteria was partially purified and studied for antibacterial characteristics using the wells technique. Analysis by bioautography and gas chromatography/mass spectroscopy (GC/MS) of the supernatant from precipitation with 100% ammonium sulphate indicated that the strain produced a high percentage of fatty acid. Additionally, a cyclic compound could be involved in the antibacterial activity. After silica plate scraping, bioactivity disappeared at 70°C. Bioactive molecule(s) may be involved in the brittle leaf disease, because its product isolated by a strain from date palm leaves is affected by the brittle leaf disease enough. In addition, this endophytic has shown best lipolytic activity and produced a lipidic biomolecule(s), this result explains the implication of metabolite(s) in the brittle leaf disease. Finally, determination of MIC and MBC of bioactive molecule(s) against strains (Bt, Bs).

Biography:

Avong am a public health pharmacist, implementer of public health initiatives and a certified operational researcher with a Master in Public Health (MPH). Avong currently pursuing a PhD in Pharmacovigilance and Pharmacoepidemiology (2P). In 2009, Avong set up a SRS in two large public health projects for the detection, monitoring, treatment and reporting of ADRs related to anti-retroviral drugs and second line anti-tuberculosis drugs. Avong have supervised the collection and analysis of over 2000 individual case reports from the projects leading to the publishing of papers in ADRs and adherence to anti-retroviral therapy (ART). Avong participated in the development of the current “Integrated National Guidelines for HIV Prevention Treatment and Care”. As the head of the Pharmacy division and Associate Director with the Institute of Human Virology, Nigeria (IHVN) – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care, I oversee the delivery of pharmaceutical care service in all the grants awarded to the IHVN. I have also served the Nigerian government as secretary of the tender committee for the importation of narcotics for the public sector. My current interest is promoting pharmacovigilance in public health programs.

Abstract:

Adverse drug reactions (ADRs) were the 4th to 6th cause of death in the United States of America (USA) in 1994. In other countries, ADRs have increased the cost of providing health care and are complicating the management of co-morbidities like HIV/AIDS and TB. Thus, in many western countries, pharmacovigilance (PV) has been instituted as an effective public health measure to protect the general population from the harmful consequences of ADRs. In Sweden, France and Italy, reporting of ADRs is compulsory. In the USA and more recently in some other countries, patients can also report directly to the spontaneous reporting system (SRS). In developing and resource limited countries, the PV systems have been weak making drug regulation a herculean task. However, in recent times, the factors that have promoted the development and strengthening of pharmacovigilance in the developed countries are now emerging in the developing countries. For instance, having a national policy on PV and a strong governmental commitment, a robust drug manufacturing sector, a vibrant health system with the potential to track and recall suspected drugs from the market, a strong central regulatory system working in collaboration with the global pharmacovigilance center and an enlightened work force, are predictors of an effective PV system. In this presentation, we shall highlight the emergence of these factors using the case of Nigeria to demonstrate the prospects of PV in resources limited countries. We shall also unveil the challenges that have to be addressed in order to strengthen PV in poor countries.

Biography:

Neerja S is a MPharma graduate from JNTU University, and PG Diploma in IPR and Regulatory Affairs from Nalsar Law university. She is heading the QA for Piramal Clinical research. She has a vast experience of 11+ years working in various departments (Quality Assurance, Medical writing, Regulatory Affairs, Site coordinator for Phase III trial) of leading CROs and pharma

Abstract:

It is very usual and common for any pharmaceutical industry to get regulatory inspections may be in manufacturing or in a CRO. Regulatory inspections guide us to make our systems more robust The presented talk will discuss about the Inspections are of majorly two types; _ Triggered by projects submitted majorly from USFDA, EU/ UKMHRA, WHO, _ To assess the system and facility which is been applied for the facility approval to conduct the trials and analysis. Eg ANVISA, MOH Turkey, DCGI. _ Key problems extracted from various Warning letter issued in Bio-analytical investigators from where the problems can be anticipated in our labs too. Also how to have a corrective and preventive action on this so that we do not have in our scenario. For Example: o Falsified laboratory records wrt - employee time/date records inconsistent and/or falsified Analytical Procedure (AP) raw data sheets o Manipulation of Samples - FDA has determined that your firm manipulated test samples in order to meet predetermined acceptance criteria _ How we can modulate our routine practice to be prepared for the inspections without any hick ups and last minute rush. o Maintenance of all calibration and qualification records. o Maintenance access control records o Maintenance of attendance of staff o Deviations to be addressed properly. _ Focus on routine activities to bring the system and facility in line to regulatory requirements so that we can bring down the non compliances drastically. o Gap analysis o RACI/ 6 Sigma like tools . o Regular IQA and focus on the closure of the same. o System department to more focus on SOP, Protocol compliance.

Biography:

Preet Mohinder Singh Bedi has completed his PhD at the age of 33 years from Guru Nanak Dev University and Postdoctoral studies from University of Bath. He is the Professor of Department of Pharmaceutical Science, a premier academic organization. He has published more than 50 papers in reputed journals and has been serving as an Editorial Board Member of repute.

Abstract:

Exports form a vital component of the growth strategy of most Indian pharmaceutical companies. The industry has made rapid strides in this area in the last few years and export sales of companies such as Ranbaxy have been growing at a faster rate than their domestic sales. The compounded annual growth rate of pharmaceutical exports over the last five years has been more than 20 percent although in 2000-2001, exports grew by 11 percent. While overall pharmaceutical exports have grown, India’s exports to a few of its leading markets have declined. For instance, India’s pharmaceutical exports to USA have declined to Rs. 671.8 crores in 1999-2000 from Rs. 724 crores in 1998-99; Germany to Rs. 325 crores from Rs. 375 crores. Notwithstanding the decline in exports to some key markets, India’s export prospects remain bright. The potential for growth is enormous, annual growth in exports over the next five years will take the overall export figure to $4 billion.

Biography:

Avong am a public health pharmacist, implementer of public health initiatives and a certified operational researcher. Avong hold a Master in Public Health (MPH) and currently pursuing a PhD in Pharmacovigilance and Pharmacoepidemiology (2P). Avong set up a SRS in two large public health projects and have supervised the analysis of over 2000 individual case reports from the projects leading to the publishing of papers in adverse drug reactions and adherence to anti-retroviral therapy (ART). Avong am the head of the Pharmacy division in the Institute of Human Virology, Nigeria – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care. My current interest is estimating the risk of medicines in public health programs.

Abstract:

Background: Spontaneous reporting systems (SRS) as the United Kingdom Yellow Card Scheme for reporting suspected adverse drug reactions (ADRs), operate in most developed and developing countries. We tested the SRS in a national cohort of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria. Methods: Using the Nigeria Yellow Form, we collected and analyzed suspected adverse drug reactions from MDR-TB patients undergoing the eight months intensive phase treatment. These patients were treated with a standard regimen, consisting of injectable Kanamycin, Amikacin or Capreomycin and oral Cycloserine, Levofloxacin, Pyrazinamide, Prothionamide and Pyridoxine for at least eight months. Characteristics of AEs were documented and risk factors assessed. Results: We included 460 patients in the analysis: 62% were males; median age and weight were 33 years [Interquartile Range (IQR):28-42] and 51 kg (IQR: 45-59) respectively. Majority of the participants (44%) experienced AEs: four died of AEs associated conditions. The most commonly reported AEs were gastro-intestinal (n=100), neurological (n=75), ototoxic (n=72) and psychiatric (n=60). Ototoxic and psychiatric AEs were debilitating and required medical intervention and hearing aids. Most AEs occurred after 1-2 months of therapy; some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Age was not significantly associated with AEs. Conclusion: The SRS proved effective at providing information on adverse drug reactions, which could aid post-marketing drug safety surveillance. Given its low cost, the SRS could be used in resource limited settings to detect, monitor and report ADRs, especially in public health initiatives like the anti-retroviral therapy programs.

Biography:

Sami Alsager is a pharmacist graduate from the college of pharmacy King Saud University Riyadh Saudi Arabia in 2002 and got a master degree in health administration from King Saud University Riyadh Saudi Arabia in 2007 he joined the SFDA in 2006. He worked in several positions including the pharmaceutical license department and now is the director of the Department of the cosmetics department.

Abstract:

Pharmaceuticals, cosmetics, medical device and food were scattered between different government organizations before the establishments of the Saudi Food and Drug Authority (SFDA) in 2004. It took the SFDA about ten years to take all the responsibility in these years the SFDA built the infra-structure and invest heavily in the training and education by sending its young generation employee to the best universities in the west. Also during this time a lot of laws, regulations and guidelines based on best international practices were written and went through the approval processes. One of these laws is the cosmetics law which is in the final stages of the approval processes. The cosmetics law will be the first in the region, and Saudi Arabia will be the first to have a comprehensive law covering all aspects of cosmetics regulations, to cover the huge market of cosmetic products which is around 2 billion dollar; some of these products are manufactured locally and some are imported from all over the world, with a market open the necessity for a good regulatory system. a system that will control the cosmetic product at the points of entry (borders) as well as in the local manufacturers until it reaches the consumer by establishing a good notification system, Cosmovigilance, developing cosmetic products safety guidelines and establishing good labs that will analyze the product to be sure it fits the standards and no hazardous material been used. In this presentation all aspects of cosmetic regulations in Saudi Arabia will be discussed.

Biography:

Ibrahim Alshowaier worked in several positions including the pharmaceutical license department and now is the director of the Department of the pharmaceuticals department.

Abstract:

Pharmaceuticals, cosmetics, medical device and food were scattered between different government organizations before the establishments of the Saudi Food and Drug Authority (SFDA) in 2004. It took the SFDA about ten years to take all the responsibility in these years the SFDA built the infra-structure and invest heavily in the training and education by sending its young generation employee to the best universities in the west. Also during this time a lot of laws, regulations and guidelines based on best international practices were written and went through the approval processes. One of these laws is the cosmetics law which is in the final stages of the approval processes. The cosmetics law will be the first in the region, and Saudi Arabia will be the first to have a comprehensive law covering all aspects of cosmetics regulations, to cover the huge market of cosmetic products which is around 2 billion dollar; some of these products are manufactured locally and some are imported from all over the world, with a market open the necessity for a good regulatory system. a system that will control the cosmetic product at the points of entry (borders) as well as in the local manufacturers until it reaches the consumer by establishing a good notification system, Cosmovigilance, developing cosmetic products safety guidelines and establishing good labs that will analyze the product to be sure it fits the standards and no hazardous material been used. In this presentation all aspects of cosmetic regulations in Saudi Arabia will be discussed.

Biography:

Doaa M Hasan works in Department of Neurosurgery Kasr el-Aini Hospital, Egypt

Abstract:

Studies had proved that cooperation between physician and pharmacist provides the patient with best health care outcome. Unfortunately, here in Kasr el-Aini Hospital there is a gap between doctors and pharmacists despite correlation between their studies and work. Clinical pharmacist has proved to be very helpful to physician in many hospitals. Despite this fact, most of medical students in Kasr el-Aini don’t know the meaning of clinical pharmacy. Students in medical college think of pharmacist as salesman. This gap leads to medical errors. It is important to study about the role of pharmacist in the process of treatment, who deals with the drug better and know more about side effect contraindication and drug interaction. This gap between our doctors and pharmacist needs to be filled to provide patients with best health care. The aim of this study is to assess the feasibility of applying the clinical pharmacy education among Kasr El-Aini medical students as well as exploring the possible collaboration perspectives between students of both medical and pharmacy colleges. Also, the study aimed to explore the team work concept among both the medical and pharmacy student after graduation. A cross-sectional descriptive study was conducted among both medical and pharmacy students. The study included 123 medical students aged from 19-24 years who agreed to participate in the study and 100 students from pharmacy colleges aged from 18-25 years. A questionnaire was distributed to the study participants to explore their training experience and measure their knowledge regarding the medical system and the treatment process flow cycle. The study revealed that 60% of medical student don’t know what the clinical pharmacist is, 7% never heard about it. Also, 14% of the medical students think the pharmacist is useless. While 69% of them, did not study about the role of pharmacist in treatment process. As for the pharmacy students, 33% of them see the doctor as arrogant person and 29% see doctor ignorant about drugs. Also, 26% of pharmacy students perceive the doctor as competitor and 29% wouldn’t accept that the doctor correct them if they admit an error about drug or drug reaction. The study revealed a wide gap between the medical and pharmacy students. They don’t know that they are on the same side, which make them as doctors and pharmacist competitors more than one team. Need to teach them how to work as one team, how to cooperate together for providing the best medical care to the patient.

Biography:

Florian M Kovar is a Professor in Department of Trauma Surgery, General Hospital Vienna, Medical University Vienna, Austria

Abstract:

Introduction: Bite wounds account for 5% of the total traumatic wounds evaluated in the ED (emergency department) and approximately 1% of all ED visits. Dog, cats, or humans provoke most mammalian bite wounds. Early estimation of infection risk, adequate antibiotic therapy and if indicated surgical treatment, are cornerstones of successful cure of bite wounds. However, antibiotic prophylaxis and wound management are still discussed controversial in the current literature. In our study we retrospectively investigated those aspects. Methods: 5.248 consecutive trauma patients were collected prospectively and analyzed retrospectively over a period of 15 years in this study at a Level I Trauma Center, Department of Trauma Surgery, Medical University of Vienna, Austria. Data for this study were obtained from our electronic patient records and follow up visits. For antibiotic therapy, amoxicillin/clavulinate (Augmentin, Glaxo Smith Kline) and in case of allergy clindamycin (Dalacin, Pfizer) were administered according to age and dosage recommended by the producer. Results: During the 15 year study period, 5.248 trauma patients met the inclusion criteria. The mean age was 33.8 years (range 0 to 97), 2.620 (49.9%) were males and 2.628 (50.1%) were females. In our study population a total of 2.530 dog-bites (48.2%), 930 cat-bites (17.8%), 357 other-animal bites (6.8%), 426 human-bites (8.1%), and 1.005 human self bites (19.2%) have been observed. A total of 995 wounds (19.0%) have been infected. Surgery was done in 132 wounds (2.5%). Conclusion: Total infection rate for sutured wounds (7.6%), and surgery were (35.6%), versus (19.4%) for open treatment. Observed infection rate of puncture wounds and wounds greater than 3 cm was 1.5 times higher than for all other wounds in the present study. Total infection rates within 24hours to antibiotic administration was 29.3%, compared to 65.0% <48 hours, and 81.1% <72 hours. Time interval also influenced the overall outcome showing a 2.6 increase in acceptable and 1.3 increase in poor outcome after 72 hours. We could demonstrate, that prophylactic antibiotics in all cases as recommended by some authors, and primary combinations of different antibiotics does not have any benefit, but might lead to higher resistance rates in patients.

Biography:

Hayam I Gad is an Assistant Professor in Physiology Department, College of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia

Abstract:

Introduction: Investigate the potential role of anti TNF- antibodies on some renal functions and release of vasoregulatory peptides using nitric oxide synthase deprived pregnant rats. Methods: The study was carried out at King Khalid university Hospital, King Saud University, Riyadh. Forty female Wistar rats were divided into four groups (10 rats each); Group I: Included virgin non-pregnant rats. Groups II: Included pregnant rats that received saline, gropuIII included pregnant rats that received NG-nitro- L- arginine methyl ester (L-NAME) while group IV included pregnant rats that received both L-NAME and anti TNF- antibodies respectively. Treatment of pregnant rats started from day 7 up to day 20 of gestation.Mean arterial blood pressure, urine volume, creatinine clearance and 24 hours urinary albumin excretion were measured on day20 of gestation. Blood samples were taken on day 20 of gestation for measurement of plasma endothelin-1 (ET-1), angiotensin II (Ag II) and serum levels of total nitric oxide (NO) products, interleukin-6 (IL-6) and soluble vascular cell adhesion molecule (sVCAM-1). Viable pups were also weighed. Results: Treatment of pregnant rats with anti TNF-α antibodies restored the urine volume, creatinine clearance, the plasma ET-1, the serum IL-6, and the serum sVCAM-1 to normal levels on day 20 of gestation. However, it showed no effect regarding serum NO. Also pup weight was insignificantly changed in anti TNF-α antibodies treated rats when compared to non treated pregnant rats. In fact administration of anti TNF-α antibodies to rats from day 7 up to day 20 of gestation decreased significantly the 24 hour urinary albumin excretion and the plasma Ag II when compared to L-NAME treated rats but still showed significant increase as compared to controls (P<0.001). Conclusion: Preeclampsia is associated with disturbed renal function, overproduction of cytokines and vasoregulatory factors, and fetal growth restriction. Treatment of pregnant rats with anti TNF-α antibodies restored urine volume, creatinine clearance, plasma ET-1, serum IL-6 and sVCAM-1 to normal levels. Hence, anti TNF-α antibodies may have beneficial effects in preeclampsia. Additional studies are warranted to confirm these results.

Biography:

Tesfaye Zerihun is graduated in Chemistry Diploma from Kotebe teaching college on JUN 2006, and employed at Addis Ababa university aklilu Lema institution of Pathobiology Research center on September 2007 as Laboratory Technician. He has worked at the entomology unit from Sep. 2007- Dec. 2011. In these Unit he experienced with different Experiment’s Like Maintaining of Insectary colonies of Malaria and Leishmaniasis vectors , preparing of Laboratory solution, Bio efficacy test on Bed-nets, Insecticide susceptibility test, blood meal and Sporozoite test with enzyme Linked Immunosorbent Assay (ELISA). He is trained on the area surveillance of insecticide resistance mosquitoes at KEMRI, Kenya. With all these experience he is assisting Master and PhD students both on the field and Laboratory. On July, 2012 he has graduated in pharmacy from Addis Ababa university School of Pharmacy and to get more experience on clinical Part he is transferred to one of the faculty of Addis Ababa University College of Health Science Black lion Specialized Teaching Hospital as a pharmacist. Currently he is working as a pharmacist on Different dispenser’s area, and Drug Supply Management coordinator, the head of special Pharmacy of the hospital, the secretory of DTC (Drug therapeutic Committee) of the hospital and assisting under graduate pharmacy students who are coming to the hospital for clinical attachment both at the warred and dispensary area. He is also participating in some of Clinical research which under go in the Hospital beside the routine work. Some of the papers which are ready for publication are- • Antibiotic conception on the Black Lion specialized Hospital • On the area of Oncology Patient in Relation to the severity of pain particularly on Breast cancer.

Abstract:

Background & Objectives: Several plant products have been tested and found to possess antileishmanial activity. The present study was undertaken to evaluate antileishmanial activity of methanolic extract of Aloe otallensis, which is endemic plant to Ethiopia, on the promastigot stage of Leishmania aethiopica and Leishmania donovani comparing to standard drugs and also tried to screen its phytochemical constitute. Methods: Phytochemical screening was done on Methanolic extract of the exudates to the leaf of Aloe otallensis. Theserial dilution of the Extract was also evaluated for in vitro antileishmanial activity against Leishmania aethiopica and Leishmania Donavan on the strain of L. aethiopica (LDC/134) and L. Donovani (AM 563), which is found from the black lion hospital parasitology unit and the result was compared to standard drug of Sodium stibogluconate, milfostin and paramomycin. Result. The extract has an antileishmaniacidal activity with an IC50 of 141 μg/ml on L. ethiopica (LDC/134) and 123μg/ml on L. donovani (AM 563). The experimental data shows that relatively it has better activity than paramomycin and milfostin but less activity than sodium stibogluconate, which is given in Ethiopia as a first line drug. The data analyses was done by pad graph prison version 5 software after it was read by ELISA redder at the wave length of 650 nm. The phytochemical screening of the exudates of Aloe otallensis showed the presence of phenol, alkaloid and saponin. Conclusion: The methanolic extract of exudate of Aloe otallensis has a good anti leishmanisis activity relatively to paramomycin and milfostin and this activity may be attributed to phenol, Alkaloid and Saponin present in the plant. But it needs further analysis for the conformation of which constituent present in much concentration and to know which one have highest role.

Biography:

Juhi Tiwari is an MPharm in pharmacology from Jayoti Vidya Peeth Womens’ University, Jaipur, India. She has attended National and International conferences and has published research paper on antipyretic effect.

Abstract:

Autism is a congenital neurological disorder characterized by impairment of socialization, abnormalities of communication, limited activity and curiosity. Clinical signs of Autism Spectrum Disorders (ASD) are frequently presented at 3 years of age with abnormalities in social, communication and play behaviour, though early indicators of autism can be detected as early as 14 months of age. Repetitive, stereotyped, and obsessive compulsive–like behaviours are also prominent features of the disorder and are oft en accompanied by cognitive impairment, seizures or epilepsy, gastrointestinal complaints, disordered sleep, and others are frequent problems in the clinical profiles of patients with autism. There are certain factors that contribute to the pathogenesis of ASD, such as dysfunctions of the serotonergic system, have been implicated in autism. The serotonergic system appears to be developmentally dis-regulated in autism. The study suggested that the clinical onset of autism appears to be preceded by two phases of brain growth abnormalities: a reduced head size at birth, then a sudden and excessive increase between 1–2 months and 6–14 months of age. Neuroimaging studies have shown that an abnormal pattern of brain overgrowth also occurs in areas of the frontal lobe, cerebellum and limbic structures between 2 and 4 years of age, a pattern that is followed by abnormal slowness in brain growth. Another study revealed that the oxidative stress might be unregulated in patients with ASDs, possibly due to decreased ability to neutralize free radicals. One study of autistic children and controls reported that plasma S –adenosyl homocysteine, which was used as an indicator of methylation ability, was signifi cantly lower in autistic children. Another study found reduced plasma levels of the key endogenous antioxidant S–adenosyl methionine. Other reviews suggested that the Erythrocyte Superoxide Dismutase (SOD) and the endogenous antioxidants plasma glutathione peroxidase and erythrocyte glutathione peroxidase (GSH-Px) were also signifi cantly reduced in autistic children. Increased mitochondrial metabolism and oxidized mitochondrial proteins in temporo-cortical gray matter in post-mortem samples from autistic patients as compared to controls was also seen. Calcitriol down-regulates production of inflamatory cytokines in the brain, which have been associated with autism. Vitamin D deficiency impairs glutathione metabolism, which may explain the link between autism and oxidative stress, as well as autism and mercury accumulation. Consumption of vitamin Dcontaining fish during pregnancy reduces autistic symptoms in children. It seems probable that autism’s neuro-developmental defect is ‘multi-domain’ in origin (rather than a single anomaly) and is, hence, distributed across numerous levels of study (genetic, immunepathogenic, etc.). A more defi nitive understanding of the pathogenesis could facilitate the development of better treatments for this complex psychiatric disorder.

Biography:

Avong is a public health pharmacist, implementer of public health initiatives and a certified operational researcher. He holds a Bachelor of Pharmacy (BPharm) from the Ahmadu Bello University, Zaria, Nigeria and a Master of Public Health (MPH) from the University of the Western Cape, South Africa. He is also in the process of pursuing a PhD in Pharmacovigilance and Pharmaco-epidemiology. In 2009, he inspired the setting- up of the spontaneous reporting system (SRS) in two public health programs (ART and MDRTB) and supervised the collection and analysis of over 2000 individual case reports (ICRs) from these programs. He has published papers in ADRs and adherence to anti-retroviral therapy (ART). Furthermore, he has peer-reviewed many manuscripts and participated in several international researches like the START study, while contributing to the development of the current “Integrated National Guidelines for HIV Prevention Treatment and Care in Nigeria”. As the head of the Pharmacy Division and Associate Director with the Institute of Human Virology, Nigeria (IHVN) – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care, he oversees the delivery of pharmaceutical care service in all the grants. He served as the liaison officer between the Martindale Pharmaceutical Limited, UK and the Federal Government of Nigeria for the importation of Narcotics for the public sector in 2003/2004. His current interest is promoting pharmacovigilance in public health programs.

Abstract:

Background: Spontaneous reporting systems (SRS) as the United Kingdom Yellow Card Scheme for reporting suspected adverse drug reactions (ADRs), operate in most developed and developing countries. We tested the SRS in a national cohort of multi drug resistant tuberculosis (MDR-TB) patients in Nigeria. Methods: Using the Nigeria Yellow Form, we collected and analyzed suspected adverse drug reactions from MDR-TB patients undergoing the eight months intensive phase treatment. These patients were treated with a standard regimen, consisting of injectable Kanamycin, Amikacin or Capreomycin and oral Cycloserine, Levofl oxacin, Pyrazinamide, Prothionamide and Pyridoxine for at least eight months. Characteristics of AEs were documented and risk factors assessed. Results: We included 460 patients in the analysis: 62% were males; median age and weight were 33 years [Interquartile Range (IQR):28-42] and 51 kg (IQR: 45-59) respectively. Majority of the participants (44%) experienced AEs: four died of AEs associated conditions. Th e most commonly reported AEs were gastro-intestinal (n=100), neurological (n=75), ototoxic (n=72) and psychiatric (n=60). Ototoxic and psychiatric AEs were debilitating and required medical intervention and hearing aids. Most AEs occurred after 1-2 months of therapy; some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Age was not significantly associated with AEs. Conclusion: The SRS proved effective at providing information on adverse drug reactions, which could aid post-marketing drug safety surveillance. Given its low cost, the SRS could be used in resource limited settings to detect, monitor and report ADRs, especially in public health initiatives like the anti-retroviral therapy programs.

Biography:

Your supply chain is critical to the success of your organizations business model. Whatever that may be! It is a fundamental pillar on which your organization can effectively provide quality products or quality services to your end customer or client. But! What if your supply chain is broken! What if one of your suppliers creates a situation that impacts not only your ability to supply your customer base but also significantly damages your brand reputation and company credibility? So! I ask you… ‘How well do you understand your vendor supply chain e.g. who is the actual manufacturer, what are the basics of how is the product made, what stages of the manufacturing process may use sub-contractors, who are the distributers and how is the integrity and quality of the supplied product controlled from the manufacturer and intermediaries to you’. How do you manage supply chain quality? How do you establish meaningful purchasing and quality agreements? How do you monitor supply chain quality? My aim in this presentation is to provide you some key areas you must consider when dealing with your supply chain; to introduce you to vendor quality agreements; and provide examples of supplier risk and monitoring techniques you can utilize in your organization to effectively manage your supply chain quality.

Abstract:

Your supply chain is critical to the success of your organizations business model. Whatever that may be! It is a fundamental pillar on which your organization can effectively provide quality products or quality services to your end customer or client. But! What if your supply chain is broken! What if one of your suppliers creates a situation that impacts not only your ability to supply your customer base but also significantly damages your brand reputation and company credibility? So! I ask you… ‘How well do you understand your vendor supply chain e.g. who is the actual manufacturer, what are the basics of how is the product made, what stages of the manufacturing process may use sub-contractors, who are the distributers and how is the integrity and quality of the supplied product controlled from the manufacturer and intermediaries to you’. How do you manage supply chain quality? How do you establish meaningful purchasing and quality agreements? How do you monitor supply chain quality? My aim in this presentation is to provide you some key areas you must consider when dealing with your supply chain; to introduce you to vendor quality agreements; and provide examples of supplier risk and monitoring techniques you can utilize in your organization to effectively manage your supply chain quality.

Biography:

Sai Sankar Prabhu Kella is studying BPharm fi nal year at K. J. R. College of Pharmacy, affi liated to Andhra University.

Abstract:

Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell. Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes aft er long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however, such as the pancreas and the heart, stem cells only divide under special conditions. Until recently, scientists primarily worked with two kinds of stem cells from animals and humans: embryonic stem cells and non-embryonic “somatic” or “adult” stem cells. The functions and characteristics of these cells will be explained in this document. Scientists discovered ways to derive embryonic stem cells from early mouse embryos nearly 30 years ago, in 1981. The detailed study of the biology of mouse stem cells led to the discovery, in 1998, of a method to derive stem cells from human embryos and grow the cells in the laboratory. These cells are called human embryonic stem cells. The embryos used in these studies were created for reproductive purposes through in vitro fertilization procedures. When they were no longer needed for that purpose, they were donated for research with the informed consent of the donor. In 2006, researchers made another breakthrough by identifying conditions that would allow some specialized adult cells to be “reprogrammed” genetically to assume a stem cell-like state. This new type of stem cell, called induced pluripotent stem cells (iPSCs), will be discussed in a later section of this document. Stem cells are important for living organisms for many reasons. In the 3 to 5-day-old embryo, called a blastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lung, skin, sperm, eggs and other tissues. In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.

Biography:

Amy Peterson is QA Manager at Quality Systems, USA.

Abstract:

Lessons learned from North America Commercial Nuclear: Design the Most Robust & Effective Deviation/CAPA System within the Pharmaceutical Industry, Predict but Monitor Effective Corrective Actions; Implement Quality Near Misses to Generate Preventive Actions, Encompass Adverse Human Error Trends; Utilize Error Prevention Techniques, Achieve Adherence to Standard Operation Procedures (SOP); Learn KEY Role of Human Factoring Processes and Instructions, Manage Human Error in Quality Systems to prevent events.

Biography:

Wael Ebied has completed his BPharm from Tanta University with Postgraduate studies from Al-Azhar University School of Pharmacy. He is a certifi ed Senior Professional, SQA Services Inc., US leader in providing supply chain management, quality and engineering services to pharmaceuticals, medical devices and highly regulated industries. He has published more than 5 papers in reputed journals and has been serving as an Editorial Board Member of repute. He has more than twenty years’ experience in pharmaceutical industries, biotechnology, medical devices and APIs. He is an accomplished technical presenter with numerous projects, scientifi c publications, participated in 1 patent and was awarded 7 premiums.

Abstract:

Humans have domesticated plants and animals since around 12,000 BCE, using selective breeding or artificial selection (as contrasted with natural selection). The process of selective breeding, in which organisms with desired traits (and thus with the desired genes) are used to breed the next generation and organisms lacking the trait are not bred, is the oldest form of genetic modification by humans. A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. GMOs are used in biological and medical research, production of pharmaceutical drugs, and experimental medicine (e.g. gene therapy). The term “genetically modified organism” does not always imply, but can include, targeted insertions of genes from one species into another. Genetically modified animals currently being developed can be used to research human diseases (for example, to develop animal models for these diseases). Transgenic animals are used as experimental models to perform phenotypic and for testing in biomedical research. Genetically modified (genetically engineered) animals are becoming more vital to the discovery and development of cures and treatments for many serious diseases. Zoopharmacognosy is a behaviour in which non-human animals apparently self-medicate by selecting and ingesting or topically applying plants, soils, insects, and psychoactive drugs to treat or prevent disease. Animals ingest non-foods such as clay, charcoal and even toxic plants, apparently to prevent parasitic infestation or poisoning. Self-medication in wild animals remains a controversial subject because evidence is mostly circumstantial or anecdotal, however, there are many purported examples. The methods by which animals self-medicate vary, but can be classified according to function as prophylactic (preventative, before infection or poisoning) or therapeutic (aft er infection, to combat the pathogen or poisoning). Although the underlying psychological and physiological mechanisms of such learned selfmedicating behavior are unclear, its adaptive value is proposed to be widespread, encompassing diseased laboratory animals. The proposal of this research article is: How human diseased-animal models will keep themselves well in an artificial wild and what we can learn from them in screening new therapeutics. The current objective is to test the hypothesis that zoopharmacognosy is operational in GMOs in artificial wild health. Once a molecular target of disease is revealed, one can use this perspective for identifying active ingredient(s) from herbal medicine in new drug discovery. The generation of transgenic animals by biotechnological techniques will provide human disease models for screening drugs of clinical interest with the help of zoopharmacognosy. Some of the compounds have been identified by zoopharmacognosy kill parasitic worms, and some of these chemicals may be useful against tumors. There is no question that the templates for most drugs are in the natural world. The question is how to discover using zoopharmacognosy by GMOs.

Biography:

Nadeem Ahmad works at Advanced Product Design Services, Canada.

Abstract:

Nucleation and coalescence are used in various chemical industries. Liquid-liquid extraction is a process in which a solute is transferred at a high mass transfer rate from a native solvent to a primary solvent which involves the addition of a primary solvent and a modifier. Extraction of efrotomycin from a fungal fermentation broth and that of beta-galactosidase from an aqueous suspension of disintegrated E. coli cells are the best examples of nucleation and coalescence of bubbles in different benzenes and liquid solutions by liquid-liquid extraction using partially miscible mixture. Conventional and high resilience foams are normally processed through the similar methods. Major factors contributing to the variation in the mechanical properties of these two types of foams are only the order of the chemical processes. During the nucleation, air is entered in the absence of surfactant. Mechanical energy of the mixing process and the surface tension of the surfactant determine the size of the foam cells. Growth of bubbles involves diffusion followed by the expansion of gas; surface tension is the cell size determining factor in this process. Growth of bubbles is followed by the process coalescence; it includes the breaking of the fluid layer between two bubbles. Coalescence may result in crack formation or collapse of the whole foam.

Biography:

Dr. Damaris Silveira is Professor at University of Brasilia, Brazil

Abstract:

Backgrounds: Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the building process of an open government is still fragile and fragmented on Health Regulatory Agencies (HRA) even on Regional Reference Authorities (RRA). Purpose: This paper assesses the transparency status of RRA, focusing on some medicine life-cycle documents (Medicine Dossier, Clinical Trial Report, and Inspection report), as tools for strengthening health systems. Methods: Through a qualitative and descriptive evaluation of regulatory transparency on RRA, it was portrayed in two different branches: information public disclosure and inter-agency data and work sharing. Results: The risk benefits of information public disclosure were assessed considering the involvement and roles of multi-stakeholders (healthcare professionals, regulators, industry, community, and academics) bearing in mind the protection of commercially and personally confidential data. Inter-agency data and work sharing were inserted in the context of harmonization and co-operation projects that focus on regulatory convergence. Conclusions: Technical and practical engagements are proposed to improve and strengthen health systems in the region of the Americas through establishment of an openness directive over pharmaceutical regulatory environment. To successfully address these challenges is crucial that regional leadershipssteer and support collaborative regional alliances toward the development and establishment of a trustful regulatory environment as well as a sustainable public health system in the Latin America and the Caribbean, using as reference international successful initiatives besides taking into account domestic characteristics and experiences of each single country.

Biography:

Mamoona Firdous Naqvi has professional experience stretched over 15 years mainly in regulatory affairs, business development and medical information with three leading organization Gulf Pharmaceutical - Julphar , Sanofi Aventis, Pakistan and Aga Khan Hospital one of the renowned hospital worldwide. In a affiliate role and regional role in some extent, she is highlighted with proven track record of achievements with consistent progression in the career, and she is equipped with dual qualifi cation–a pharmacist (graduate in pharmacy and Master in Pharmaceutical Sciences) and MBA in Marketing discipline (First class First, Gold Medallist). She has solid understanding of product development, good interpersonal skills, and has excellent communication skills with sensitivity for confidential information and socio-cultural issues, strong planning skills with proven competence in establishing new processes for faster market access, and she is expertise in develop and implement regulatory strategies, appreciation for cultural diversity and team work.

Abstract:

The skin is the body’s largest organ. Nevertheless, the importance of its functional role is oft en underestimated, and its care is taken for granted. Establishing a skin care regimen is important to maintain healthy, hydrated skin, and incorporating preventive measures can help reduce or eliminate exacerbating conditions that may make unprotected skin more susceptible to dermatologic problems. Pharmacists receive frequent requests for information about various skin care products available for cleansing, moisturizing, and photo protecting the skin. As accessible health care professionals, pharmacists are in a key position to educate patients about appropriate skin care, especially the necessity of using moisturizers several times a day to improve the skin’s appearance and texture and sustain its protective function. To understand the importance of moisturizing the skin and factors that may make the skin more susceptible to dryness, pharmacists must be familiar with the skin’s physiology. Such knowledge allows pharmacists to make appropriate recommendations to patients about skin care products. The goals of therapy are to restore the hydration and barrier function of the skin. To that end, the patient should be educated in how to establish a routine cleansing and moisturizing regimen. The Role of the Pharmacist: When counseling patients, pharmacists should take the opportunity to increase awareness about the importance of a daily skin care regimen and explain the consequences of not taking care of the skin. If necessary, pharmacists should refer patients to a dermatologist. Pharmacists can be instrumental in identifying individuals who may be at a greater risk for developing dry skin, particularly those currently taking prescription medications or those with certain medical conditions. For example, approximately 33% of patients with diabetes have some type of dermatologic disorder that is the result of or affected by the diabetes. Through pharmacists’ counseling, patients with diabetes can be reminded that, in addition to maintaining glycemic control, it is also imperative to adhere to a daily skin care regimen that includes mild cleansers and moisturizers to prevent further complications associated with dry skin. As health care professionals, pharmacists can provide expertise, knowledge, and advice to patients about skin care products and the health benefits of healthy, hydrated skin.

Biography:

Lantider Kassaye Bekele is a Pharmacist by profession and has completed his MSc degree in Pharmaceutical Analysis and Quality Assurance from Addis Ababa University, Ethiopia. He had worked in Food, Medicine and Healthcare Administration and Control Authority (FMHACA) of Ethiopia in different positions. He has published more than five scientific papers in the international journals in his field. He was the Chairperson of the National Technical Committee for Standards of Alcoholic Beverage. He has served as a Member of Pharma Forum Committee, Ethiopian Pharmaceutical Association. Moreover, he was a Member of Drug Advisory Committee of the Regulatory Authority. Currently, he is working for GlaxoSmithKline Ltd as Regulatory Executive for Ethiopia and Djibouti.

Abstract:

Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals manufactured below established standards of quality and therefore dangerous to patients’ health and ineffective for the treatment of diseases. Counterfeiting occurs both with branded and generic products. The 2008 report of WHO on the estimation of the proportion of counterfeiting by category revealed that the most counterfeited drugs were in the genito-urinary category (37 percent) followed by anti-infective (12 percent) and central nervous system drugs (12 percent). Amoxicillin is one of the most susceptible medicines for counterfeiting in Ethiopia because of its high demand in the market. Ten brands of amoxicillin in solid oral dosage forms were subjected to analysis according to USP (2011) monograph for identification, uniformity of dosage units, assay and dissolution performance. Results indicated that all of the samples were in accordance with the pharmacopoeia specifications. However, seventy percent of the tested products fulfilled dissolution test aft er stage II. And hence, more study was done on the dissolution profiles of the capsules. The in vitro dissolution profiles were compared using dissolution efficiency model. Only one of the eight brands was found to be similar with the innovator brand. Therefore, from the study, it can be understood that even though ninety percent of the tested samples were not identical with the innovator brand, they fulfill the pharmacopeial requirements. Further studies need to be done on other antiinfective, genito-urinary and central nervous system drugs. Remarkable attention should be given for expensive, highly demanded and easily degradable medicines in order to assess and look into the existence of counterfeit and sub-standard drugs.

Biography:

Rashid Mahmood has 12 years diversified work endurance of Laboratory Management, Quality Assurance, Registration Affairs, GMP Requirements, Drugs Laws, Statistical Methodology, Method Validation, Process & Cleaning Validation, Certifi cate Courses on cGMP, cGLP, Process Validation, ISO/IEC 17025:2005, 14001:2004, OHSAS 18001:2007, and 9001:2008 QMS with strong scientifi c, analytical, statistical, planning, managerial and training skills. Currently he is working as a Senior Manager Quality Operations for Surge Labs (Pharmaceutical Plant) which is the best export oriented company in Pakistan.

Abstract:

In the pharmaceutical industry every product and every process is associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in -recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most. QRM improves risk awareness and accelerates detection of potential issues by analyzing and comparing existing data from a quality perspective to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. In addition quality risk management improves decision making if a quality problem arises. It should include systemic processes designated to co-ordinate, facilitate and improve science-based decision-making with respect to risk. Quality Risk Management can be applied not only in the manufacturing environment, but also in connection with pharmaceutical development and preparation of the quality part of marketing authorization dossiers. The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorization dossier, GMP inspections and the handling of suspected quality defects. ICH Q9 - Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decision making applications. It is a landmark document in acknowledging risk management as a standard and acceptable quality system practice to facilitate good decision-making with regard to risk identification, resource prioritization, and risk mitigation / elimination, as appropriate.

Biography:

Tariq Jamshaid has 11 years diversifi ed work experience of Quality Control, Manufacturing Processes, Pharmaceutical Product Design & Development, Process Optimization, Laboratory Management, Drug Registration Processes, GMP Requirements, Drugs Laws, Statistical Methodology, Manufacturing Process Validation, Cleaning Validation, ISO 9001:2008 with strong scientifi c, analytical, statistical, planning, managerial and training skills. Currently he is working as a Sr. Manager Production & Development for Surge Laboratories Private Limited, Pakistan.

Abstract:

Novel Drug delivery System (NDDS) refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects. NDDS is a system for delivery of drug other than conventional drug delivery system. NDDS is a combination of advance technique and new dosage forms which are far better than conventional dosage forms. Advantages of Novel Drug Delivery System are: Optimum dose at the right time and right location, Efficient use of expensive drugs, excipients and reduction in production cost, Beneficial to patients, better therapy, improved comfort and standard of living. Basic modes of novel drug delivery systems are: Targeted Drug Delivery System, Controlled DrugDelivery System and Modulated Drug Delivery System Factors affecting the design of controlled release products are: Physicochemical properties of a drug, Route of administration, Acute / Chronic therapy, Target sites, The Patient, The disease state/level. Classification of novel drug delivery system with reference to release control is: 1. Matrix diffusion types (In which rate of release is controlled by diffusion of dissolved drug in the matrix). a. Rigid Matrix Diffusion (in which insoluble plastic materials like PVP & fatty acids are used. b. Swellable Matrix Diffusion (in which Hydrophilic gums like guar gum, tragacanth, HPMC, CMC, Xanthan Gum & Polyacrilamides are used). These are also called Glassy Hydrogels and popular for sustaining/control the release of highly water soluble drugs. c. Reservoir System (in which polymer content in coating, thickness of coating & hardness of micro‐capsules control the release of the drug). 2. Dissolution Matrix Type (in which drug is homogeneously dispersed throughout in a rate controlling medium waxes like bees wax, carnuba wax, hydrogenated castor oil, which control the drug dissolution by controlling the rate of dissolution). a. Encapsulation (in which dissolution is controlled by dissolution controlling coating system like use of cellulose, Polyethylene. Glycols, polymethylacrylates and waxes. Dissolution rate also depend upon coating material stability and thickness of coating film. 3. Dissolution & Diff usion Controlled Release System (in which drug is encapsulated in partially soluble membrane, pores are created due to soluble parts of coating film which permits entry of aqueous medium into core and drug dissolution starts by diffusion of dissolved drug out of system. Mixture of water soluble PVP and water insoluble ethyl cellulose is used for this purpose). 4. Water penetration/Osmotic Pressure Controlled NDDS 5. Chemically controlled NDDS 6. Hydrogels (in which three dimensional structures of hydrophilic polymers having chemical and physical cross links provide a network structure to hydrogels. These are insoluble due to network structure and provide desirable protection of liable drugs, proteins and peptides). 7. Ion Exchange Resins Controlled Release Systems

Biography:

Nadeem Ahmad is a researcher at Advanced product design services, Canada

Abstract:

Nucleation and coalescence are used in various chemical industries. Liquid-liquid extraction is a process in which a solute is transferred at a high mass transfer rate from a native solvent to a primary solvent which involves the addition of a primary solvent and a modifier. Extraction of efrotomycin from a fungal fermentation broth and that of beta-galactosidase from an aqueous suspension of disintegrated E. coli cells are the best examples of nucleation and coalescence of bubbles in different benzenes and liquid solutions by liquid-liquid extraction using partially miscible mixture. Conventional and high resilience foams are normally processed through the similar methods. Major factors contributing to the variation in the mechanical properties of these two types of foams are only the order of the chemical processes. During the nucleation, air is entered in the absence of surfactant. Mechanical energy of the mixing process and the surface tension of the surfactant determine the size of the foam cells. Growth of bubbles involves diffusion followed by the expansion of gas; surface tension is the cell size determining factor in this process. Growth of bubbles is followed by the process coalescence; it includes the breaking of the fluid layer between two bubbles. Coalescence may result in crack formation or collapse of the whole foam.

Biography:

Mamoona Firdous Naqvi has professional experience stretched over 15 years mainly in regulatory affairs, business development and medical information with three leading organization gulf pharmaceutical - julphar , Sanofi aventis, pakistan and Aga khan hospital one of the renowned hospital worldwide , in affiliate role and regional role in some extent, highlight with proven track record of achievements with consistent progression in the career, equipped with duel qualification – a pharmacist ( graduate in pharmacy and master in pharmaceutical sciences ) and MBA in marketing discipline ( first class first,gold medallist )

Abstract:

The skin is the body\'s largest organ. Nevertheless, the importance of its functional role is often underestimated, and its care is taken for granted. Establishing a skin care regimen is important to maintain healthy, hydrated skin, and incorporating preventive measures can help reduce or eliminate exacerbating conditions that may make unprotected skin more susceptible to dermatologic problems. Pharmacists receive frequent requests for information about various skin care products available for cleansing, moisturizing, and photo protecting the skin. As accessible health care professionals, pharmacists are in a key position to educate patients about appropriate skin care, especially the necessity of using moisturizers several times a day to improve the skin\'s appearance and texture and sustain its protective function. To understand the importance of moisturizing the skin and factors that may make the skin more susceptible to dryness, pharmacists must be familiar with the skin\'s physiology. Such knowledge allows pharmacists to make appropriate recommendations to patients about skin care products. The goals of therapy are to restore the hydration and barrier function of the skin. To that end, the patient should be educated in how to establish a routine cleansing and moisturizing regimen. A variety of strategies can be incorporated into a daily routine to prevent and treat dry skin. Selection of proper cleansers and moisturizers is essential to ensuring healthy skin; thus, pharmacists should evaluate the patient\'s medical and medication history and inquire about the patient\'s current skin care regimen, including types of cleansers and/or moisturizers used and the frequency of use. Referral to a dermatologist is recommended for patients with severe dry skin.

Biography:

Boyd L. Summers is a Quality Technology Consultant for BL.Summers.Consulting.LLC located in Seattle, Washington. He has 30 years of experience and continues to solve complex quality problems are addressed, resolved and compliant. author of the two software technology books titled; “software engineering reviews and audits.” and “effective methods for software and systems integration. boyd provides software articles to software engineering journals and magazines. topics include:system design, software requirements, software design, software test and evaluation, configuration management, quality assurance, process and product evaluations. applies processes in agile, lean and six-sigma including a software technology speaker at conferences and member of the American Society Quality (ASQ).

Abstract:

Quality Assurance personnel are trained and chartered to partner with companies and/or institutions to instill quality, maintain process and requirements compliance thru in-house quality audits, evaluations and provide quality oversight. Quality is a practice to exam processes to ensure conformance to required standards and contract requirements and to show the values of quality practices. For creating a community to working together and establish an inspired future and customers is important. Quality values drive the growth of people and businesses through personal and professional development focused on disciplined execution and quality. Companies and/or institutions must maintain historical records (electronic or paper) such that they accurately reflect the activities and status they represent. Records are required by Quality Assurance to audit and provide effective evaluation to ensure contract, and company requirements are retained by Quality Records.

Biography:

Osemeke U. Osokogu completed his medical training at the University of Benin, Nigeria. He has received additional trainings in Statistics, Public Health, Pharmacovigilance and Pharmacoepidemiology from institutions in Belgium, France and the Netherlands. Currently, he is conducting pediatric drug safety research at the Department of Medical Informatics, Erasmus Medical Center (Rotterdam). He is about completing the requirements for a PhD degree. In addition to (co)-authoring (about to be) published manuscripts, he has peer-reviewed manuscripts for journals of international repute. He is non-executive director of a not-for-profit organization that aims to stimulate the conduct of health-related research within the African continent.

Abstract:

In order to generate pediatric-specific drug safety (and efficacy) evidence, the US Pediatric Research Equity Act (PREA) and the EU Pediatric Regulation were passed in 2003 and 2007 respectively. While some safety evidence may be generated from pre-marketing studies, important evidence regarding rare and delayed-onset adverse effects may be missed. Analysis of spontaneous reporting systems is the most common method for post-marketing drug safety surveillance, but unlike the general population, little research effort has focused on improving surveillance in the pediatric population specifically. Yet unlicensed and off-label drug use; and organ maturation and changing hormonal levels, both of which impact drug pharmacokinetics and Pharmacodynamics, predisposes this vulnerable population to adverse drug reactions. Available data may be used for pediatric drug safety monitoring but pediatric-specific methods are not available. Methods that have been applied to the general population may be tailored to the specific needs of the pediatric age group, however a pediatric-specific reference set of drug-adverse event associations is required. Osokogu et al. 2015 reported on the creation of such a reference set; currently it is being applied to evaluate the performance of selected signal detection methods. Preliminary results are promising, however there are challenges. Time is crucial to the definition and application of a reference set when such is used for methods’ evaluation. Yet, the confirmation of adverse drug events is country-specific. Age may impact methods’ performance. These (and other) challenges must be overcome if we are to improve drug safety monitoring in the pediatric population.

Biography:

Vladimir Popov is the Head of Clinical Pharmacology Department of Scientific Medical Center of JSC “Russian Railways”. He obtained his MD with an honorary degree, a Master of Internal Medicine, PhD in Cardiology. He has completed Doctor of Medical Science in 2007. He has over 18 years of experience in clinical trials. He has published more than 140 articles and abstracts and directed numerous symposia.

Abstract:

Over the last years a number of factors have an influence on the market of clinical trials and prompted changes. Drug developers tend to define intrinsic and extrinsic factors of interregional differences which can influence an outcome of international clinical trials. The increase in R&D costs should be taken into consideration because the activity of trials and developmental activity has been increasing over the last decade, but the number of new drugs’ approvals has officially decreased. Analysis of the results of inspections of FDA/EMA and Russian authorities over the last 5 years does not show an improvement in the quality of trials and clinical trials inspections by the IRB/IECs and Sponsor. The results of the FDA inspections related to the frequency of clinical investigator-related deficiencies based on post-inspection correspondence issued showed that the situation has not changed positively either; thus in 2011, out of 407 Domestic and Foreign inspections, 128 had findings (31%), and in 2014, out of 472 inspections - 171 (36%) had findings in the category “Protocol violations”. The above-mentioned factors influence the clinical trials' quality and require the compliance to quality standards from all parties who organize and conduct clinical trials. The risk-based management, that is, one of approaches to solving the problem, has been implemented on a wide-scale. On the part of the regulatory authorities (FDA/EMA), regulatory-procedures harmonization is being introduced. The number of risk-based inspections, co-inspections of FDA/EMA/Russian regulatory authorities, is increasing; the training of inspectors is being harmonized.

Biography:

Andy Moreno is a Bacterial Pathogen Surveillance Systems Engineer with HSG/AME Certified Laboratories, LLC. He works with food production managers to engage test and release programs to assure that food shipped to the market is not contaminated with food borne pathogens. He has worked at NASA, Thermo Finnigan, Cepheid, and other firms pursuing the direct application of solutions relating to scientific endeavors.

Abstract:

Microbiological data collected by traditional methods are inherently variable. The "plate count" is at best an interpretation of an approximation of the number of cells present. Colony Forming Units (CFU) method analysis is only an estimate of the number of cells present. It is a skewed estimate at best as the only cells able to form colonies are those that can grow under the conditions of the test (e.g., incubation media, temperature, time, oxygen conditions). Traditional methods require days before the results can be interpreted and reported to decision-makers in a production setting. The use of real-time polymerase chain reaction (RT-PCR) technologies with a total bacteria screen (TBS) assay permits the detection of the DNA of all bacteria within 35 minutes. The use of RT-PCR TBS assays allows process control/quality control managers precious time and additional specificity and sensitivity prior to decision-making.

Biography:

Puthucode N Rajamani is the President of “Rajamani Group, LLC” and is a Quality Assurance and Compliance Professional with expertise and a proven record of success in the Design and Implementation of Quality Systems and Manufacturing Systems. He has extensive experience working with both major pharmaceutical companies and contract manufacturers on a global basis. He has more than 40 years of industry experience and has worked in pharmaceutical research, development, and formulation, pharmaceutical and biotech production, project and process engineering, validation and process automation during his career at Pfizer Inc., Smith Kline Beecham, Baxter International, Squibb, Union Carbide, France, Italy, and Belgium Atomic Energy Consortium. He is presently providing consulting services to major Biotech and Pharmaceutical companies in all areas of regulatory and cGMP compliance.

Abstract:

Communication, after all, is the tool you use every day to build your closest relationships, and experts (as well as common sense) tell us that the right words, spoken in the right way, can work wonders on even the testiest interactions. So what is the problem? Most of us think we’re good communicators, but research shows we’re surprisingly unskilled at it. According to ground-breaking work in the field of neuroscience, however, it’s easy to retrain ourselves to speak and listen in a way that stimulates sympathy and trust in the other person’s brain in a matter of seconds. This presentation hopes to achieve the following listed objectives: • Building Cross Cultural Effectiveness • Profiles of National Cultures Using the Cultural Orientation Approach • Receptive to cross-cultural learning and maintains an open and productive attitude toward difference. • Avoids quick judgment • Tolerates ambiguity and complexity in cross-cultural social situations. • Remains patient with others. • Continually pursues learning about other cultures. • Maintain focus and prioritize work • Learn good decision making process in a consistent manner • Obtain cooperation by communicating the risks and gains of appropriate decisions • Effective management of communications both within and outside the organization. The 24 soft-skills identified here helps towards a better dialogue and communication with a friend, a spouse or a colleague at work.

Biography:

Anthia Zammit completed her Bachelor of Laws (LL.B), and Doctor of Laws (LL.D) degrees, at the University of Malta. She advises multinational mega-cap and start-up companies operating in healthcare, life sciences, biotechnology, and pharmaceutical industries. She has experience in global expansion in established and emerging markets; medicinal product launches, drug and vaccine licensing, regulatory compliance (EU-GMP and EU-GDP), pharmacovigilance, data privacy, pricing, and marketing. She worked at the Office of the CEO of Malta’s national competent authority, the medicines authority (the “Malta FDA”). Anthia Zammit regularly participates as a guest speaker at high-level conferences on invitation of the European Commission.

Abstract:

The World Health Organization views vaccines as an important solution to averting public health crisis. Under EU legislation, vaccines are defined as “medicinal products”, and are as such subject to regulatory requirements. As pharmaceutical products, vaccines carry benefits as well as risks. In response to complications and diseases that occur following vaccination, various countries have implemented vaccine-injury compensation programs. In the US, the Vaccines Act of 1986, and the Supreme Court judgment Russell Bruesewitz et al v. Wyeth et al. (decided February 22, 2011), substantially reduced the pharmaceutical manufacturer’s civil liability, even for mandated drugs. What steps are being taken by the pharmaceutical industry to ensure a higher level of vaccines safety? The best age of tolerance to an antigen; the number of vaccines that have the best clinical outcomes; the spacing out of vaccines; the right dosage; and the lowering of mercury and aluminum levels would be revised and updated via legislation and policy. There should be a way for the regulators to step in and with their teams, define the nature of the vaccines, their quality free of potential toxic reagents, and how and when the vaccines should be delivered. This would however come at a substantial cost to stakeholders, particularly the pharmaceutical industry.

Biography:

Wael Ebied has completed his BPharm at the age of 23 years from Tanta University with Postgraduate studies from Al-Azhar University School of Pharmacy. He is a certified Senior Professional, SQA Services Inc., US leader in providing supply chain management, quality and engineering services to pharmaceuticals, medical devices and highly regulated industries. He has published more than 5 papers in reputed journals and has been serving as an Editorial Board Member of repute. He has more than twenty years’ experience in pharmaceutical industries, biotechnology, medical devices and APIs. He is an accomplished technical presenter with numerous projects, scientific publications, participated in 1 patent and was awarded 7 premiums.

Abstract:

Humans have domesticated plants and animals since around 12,000 BCE, using selective breeding or artificial selection (as contrasted with natural selection). The process of selective breeding, in which organisms with desired traits (and thus with the desired genes) are used to breed the next generation and organisms lacking the trait are not bred, is the oldest form of genetic modification by humans. A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. GMOs are used in biological and medical research, production of pharmaceutical drugs, and experimental medicine (e.g. gene therapy). The term "genetically modified organism" does not always imply, but can include, targeted insertions of genes from one species into another. Genetically modified animals currently being developed can be used to research human diseases (for example, to develop animal models for these diseases). Transgenic animals are used as experimental models to perform phenotypic and for testing in biomedical research. Genetically modified (genetically engineered) animals are becoming more vital to the discovery and development of cures and treatments for many serious diseases. Zoopharmacognosy is a behavior in which non-human animals apparently self-medicate by selecting and ingesting or topically applying plants, soils, insects, and psychoactive drugs to treat or prevent disease. Animals ingest non-foods such as clay, charcoal and even toxic plants, apparently to prevent parasitic infestation or poisoning. Self-medication in wild animals remains a controversial subject because evidence is mostly circumstantial or anecdotal, however, there are many purported examples. The methods by which animals self-medicate vary, but can be classified according to function as prophylactic (preventative, before infection or poisoning) or therapeutic (after infection, to combat the pathogen or poisoning). Although the underlying psychological and physiological mechanisms of such learned self-medicating behavior are unclear, its adaptive value is proposed to be widespread, encompassing diseased laboratory animals. The proposal of this research article is: How human diseased-animal models will keep themselves well in an artificial wild and what we can learn from them in screening new therapeutics. The current objective is to test the hypothesis that zoopharmacognosy is operational in GMOs in artificial wild health. Once a molecular target of disease is revealed, one can use this perspective for identifying active ingredient(s) from herbal medicine in new drug discovery. The generation of transgenic animals by biotechnological techniques will provide human disease models for screening drugs of clinical interest with the help of zoopharmacognosy. Some of the compounds have been identified by zoopharmacognosy kill parasitic worms, and some of these chemicals may be useful against tumors. There is no question that the templates for most drugs are in the natural world. The question is how to discover using zoopharmacognosy by GMOs.

Biography:

Thais dos Santos Paulino Soares did her Master’s degree in Pharmaceutical Sciences from the Federal University of Ouro Preto. She graduated in Pharmacy, also from UFOP, in 2013. Currently, she is pursuing MBA in Regulatory Affairs at the Instituto de Pós Graduação (IPOG), in Belo Horizonte, Brazil.

Abstract:

Dissolution testing conducted in physiological similar conditions is an useful tool in predicting issues related to pharmacokinetics, may indicate bioequivalence between certain products as solid oral dosage forms, and is employed to optimize the development and ensure the quality of drug formulations. According to Brazilian Health Surveillance Agency (Anvisa), European Medicines Agency (EMA) and Food and Drug Administration (FDA), comparative dissolution testing is required as a previous stage to the bioequivalence study between the new drug application (NDA) and abbreviated new drug application (ANDA), and also between NDA and similar (ANDA designated by a trademark) in Brazil. For oral suspensions, little information is available in the literature about the dissolution testing conditions, such as insertion and collection of the sample, influence of the system agitation, and others. In 1995, the first monograph including suspension dissolution testing was published in the United States Pharmacopeia (USP) 23. Dissolution testing was mentioned in one suspension monograph in Brazilian Pharmacopoeia 4th edition (2005) which was excluded in the 5th edition (2010). In USP 36 (2013), 12 suspension monographs include the test. Currently, 13 NDA, 17 ANDA and 9 similar oral suspensions are registered in Anvisa. Out of these, two (15.4%) NDA, three (17.6%) ANDA and one (11%) similar have monographs with dissolution test in USP 36. In this scenario, the establishment of the dissolution test conditions and its relevance in predicting in vivo performance of suspensions is paramount to subsidize their registration by the regulatory agencies.

Biography:

Debi Silber is an MS, RD, WHC, FDN The Mojo Coach, and currently is the President/CEO of Lifestyle Fitness, Inc. and the Founder of www.DebiSilber.com and www.TheMojoCoach.com. She is a recognized health, weight loss, fitness, wellness, lifestyle, personal development expert, speaker, consultant, coach and author of 2 books recommended by Brian Tracy, Marshall Goldsmith, Jack Canfield and many more. She branded The Mojo Coach because she has led countless others to achieve their ultimate body, mind, image and lifestyle; inspiring them to "get their mojo back" and helping them transform into their personal and professional best. In addition to being a highly credentialed and awarded Health Expert, she has her own line of deliciously healthy Mojo Fuel Barsâ„¢ and shakes and is a contributor to the Dr. Oz show, CBS, Shape, Self, Health, Working Mother, Psychology Today, WebMD, Yahoo Shine, Ladies Home Journal, MSN, Woman's World and Glamour to name a few.

Abstract:

Being an impactful leader takes improving both your inner and your outer game. It takes: (1) A lean, fit body filled with energy and vitality, (2) A mindset that propels you to be, do and have more, (3) A dynamic, charismatic and magnetic image that invites people to want what you have, (4) A lifestyle that not only supports but amplifies your growth. It’s not as hard as you think when you focus on 4 crucial areas that need to be strengthened in order to become your personal/professional best and Debi Silber, The Mojo Coach® will show you how. She’ll share the secrets and strategies you need to create a dynamic leadership presence along with the tools top leaders implement to create that winning edge. You’ll learn (1) The 4 crucial areas to strengthen in order to become your physical, mental and emotional best, (2) How your beliefs, behaviors, habits, relationships and stress level are causing health/wellness or illness/disease, and what to do about it, (3) How to purposefully, powerfully and passionately lead your group, team or simply your own children, (4) How to create a dynamic, charismatic and magnetic presence so you convey confidence and trust.