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.