Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Chicago, Illinois, USA.

Day 2 :

Keynote Forum

Eliana Silva de Moraes

ABPVS, Brazil

Keynote: Global regulatory challenges and implications

Time : 09:30-10:00

Regulatory Affairs 2017 International Conference Keynote Speaker Eliana Silva de Moraes photo
Biography:

Eliana has her expertise in Food and Drug Law. She has 26 years’ experience in helping international pharmaceutical, health and food companies to gain presence in markets of Latin America and Europe, specially. She has an active participation in the harmonization of regulatory affairs process through the organizations that she represents. She has played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first Anvisa’s President in USA to explore the US specially the Food and Drug Administration (FDA) and Paho, in December 1998. She is President of the ABPVS a Regulatory Affairs Organization for Brazil and Latin America Countries and Lawyer at Silva de Moraes, Member of the Brazilian Bar Association and The Portugal Bar Association.

 

Abstract:

Becoming a global company is an impressive task specially to make strategic decisions for the product approval. One of huge challenges is the lack of uniform standards and regulations when selling and marketing in another country than of the product origin. It is impossible for to standardize a single application form of a product registration for different countries. Because of this the regulatory process can be costly and the product approval can take time. So, companies that intend to launch a product in an international market must think to develop a good regulatory strategy that allows dealing with each country separately (most of the time) and their regulatory staff needs to acquire knowledge to help accomplish with the regulations, locally. The purpose of this topic is to find common elements in the most varied regulatory systems that enable companies to more accurately identify the documents and information required by international regulators and understand technics that can help to reduce cost and time in the registration approval process globally. An analysis of the legislation of the different countries for the approval of registration of medical equipment and an identification the common elements will be discussed in a practical way.

 

Keynote Forum

Stephen F Amato

Northeastern University, USA

Keynote: Convergence of regulatory affairs and reimbursement/market Access

Time : 10:00-10:30

Regulatory Affairs 2017 International Conference Keynote Speaker Stephen F Amato photo
Biography:

Stephen F Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. He is the Program Director of the Biomedical Regulatory Affairs Program in the Professional Advancement Network (PAN) at Northeastern University. Steve has also been the Managing Director of tJun 17 Life Sciences, LLC, an organization that facilitates the global commercialization of early stage medical technologies. Prior to founding and directing operations at Jun17 Life Sciences, Steve was the Executive Director of Marketing at Anika Therapeutics where he served as the Head of Anika's Marketing Department. In this role he
managed all aspects of the company's product portfolio including market segmentation, targeting, and positioning, pricing and promotional strategies. From 2000 to 2007 he was the Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed a $140 M orthopedic product portfolio. Earlier in his career, Steve worked for Visible Genetics, where he was responsible for developing and launching genomic molecular diagnostics products used for subtyping Human Papilloma Virus (HPV) and other infectious disease agents. He has also worked with Critical Therapeutics on the development and commercialization of treatments for gram-negative sepsis. Steve holds an AB in Biochemical Sciences from Harvard University, a in Molecular and Cellular Biology from Boston College’s Graduate School of Arts & Sciences, and an MBA from the Carroll School of Graduate Management at Boston College. He has also received the US Regulatory Affairs Certification (RAC) designation and is a Consultant for the Regulatory Affairs Professional Society (RAPS).

Abstract:

The purpose of this study is to describe the evolution of convergence drivers between global regulatory science and reimbursement paradigms, outline the similarities and differences between 'safety and efficacy' and 'reasonable and necessary and to explain how cost effectiveness variables can be considered during evaluation of drug approval applications. In the European Union, specifically the UK and Germany, regulatory approval and reimbursement determination for biomedical products goes hand in hand. But few biomedical product companies in the US have taken advantage of the pilot programs that enable, for example, the parallel pursuit of both FDA approval and CMS national coverage determinations. These are
intended to alleviate some of the process heavy FDA and CMS requirements that the industry often views as hampering innovation. At the same time, pursuing both approvals to market and universal coverage with Medicare in parallel can seem daunting to biomedical product developers. It calls for smarter study design that matches the expectations of the FDA, CMS and private payers. That means not only focusing on clinical endpoints that prove the products to be safe and effective, but also demonstrating that the product is reasonable and necessary, and superior to others in its category. This presentation will outline both the benefits to the parallel review pilot program on the device side and the key factors device developers need to consider when pursuing a joint approval, including: Advocate for more transparency in the process – medical device
companies often shy away from opening the door to a conversation with the FDA, but in this case, dialog and gathering as much information as possible is key; establish guiding principles – timelines and expectations for both the FDA and CMS need to be clearly defined before trials begin; know when to call it quits–device developers can withdraw from the process at any time and need to see and interpret signs for decoupling the pursuit of both milestones. Through better design of the clinical development process, biomedical product manufacturers can address both regulatory science as well as payer standards during the commercialization process.

  • Global Regulatory Affairs | Regulatory Enforcement & Inspection | Audits and inspections | Good Laboratory Practices| Good Pharmacovigilance Practices
Location: Zurich
Speaker

Chair

Stephen F Amato,

North Eastern University, USA

Speaker

Co-Chair

Eliana Silva de Moraes

ABPVS, Brazil

Session Introduction

Diadelis Remirez Figueredo

Devices and medical equipments (CECMED), Cuba

Title: Pharmacogenetic: Regulatory considerations, cuban guidance

Time : 12:20-12:40

Speaker
Biography:

Diadelis Remirez Figueredo has received her BA in Biochemistry from Havana University, Cuba and both her MSc in Biomedicine and PhD in Pharmaceutical
Sciences from National Center for Scientific Research in Havana and most of the results were done in the Department of Toxicology at the Free University in
Amsterdam. Her Postdoctoral training in Molecular Toxicology and Pharmacology was completed at the Faculty of Pharmacy in Toronto, Canada. She has been a referee of scientific journals. She has been the recipient of National Award of Pharmacology twice from the Cuban Pharmacology Society. She has worked as an expert for the evaluation of preclinical platform in South Africa (CSIR). She is currently the Vice President of Cuban Pharmacology Society. Presently she works in the Cuba Regulatory Agency and she is one of the Reviewers for authorization of clinical trials. She is the Project Leader about Pharmacogenetic guideline. She belongs to Iberoamerican Pharmacogenetic Network (RIBEF) since 2008 and recently obtained Master degree in Clinical Trials. Her research is described in over 30 published research reports.

Abstract:

The science of pharmacogenomics has advanced significantly in the last five years. The Pharmacogenomics helps identify inter-individual variability in drug response (both toxicity and effectiveness). This information will make it possible to individualize therapy with the intent of maximizing effectiveness and minimizing risk. This discipline is a big challenge for regulatory authorities. The aim of this work is to present the bases of pharmacogenetic, the state of art and implications of this discipline for Latin-American countries and to show the Cuban Guidance for Industry. International literature was reviewed about the existing regulations, guidance, concept paper, scientific articles and the national regulations related with the topic. The results showed that there are several normative and guidance related with pharmacogenomic; the increase of biological product registration and authorized clinical trials in Cuba and the necessity for carrying out pharmacogenetic studies during the clinical phases of our products. We will show the main biomarkers for pharmacogenetics studies and a Cuban general
guidance for submission of this type of research. It is divided mainly in four sections: Introduction, objectives and scope, terms and definition and regulatory recommendations (reception, codification and sample storage biomarkers, and ethical considerations). This Cuban guidance will be considered the first guidance related with pharmacogenomic in Latin America.
Pharmacogenetic has several advantages in order to get rational use of drugs but still there are many challenges. The hope for the future is that through personalized medicine, doctors and patients will be able to make better-informed choices about treatment.

Speaker
Biography:

Abstract:

Cancer molecular diagnostics has rapidly grown through the utilization of the prognostic algorithm and the predictive biomarker for patients. Nucleic acid extracted from formalin-fixed, paraffin-embedded tissues (FFPET) is frequently subjected to dispute because it causes extensive damage and produces imprecise diagnostic result, while it is the most widely used resource for molecular diagnostic analysis. Moreover, the false result of mutation analysis by damaged nucleic acids could cause serious problems in diagnostic fields. Artifactually sequence variants arising from nucleic acid damage in FFPET will be more frequently detected because of stochastic enrichment in the low copy number context increases the risk of false positives. A large amount of previous clinical researches have neglected the quality of samples yielded controversial results. Thus, the evaluation and standardization for the quality of nucleic acid samples should be considered to apply nucleic acids
from FFPET to the molecular diagnostics. In the last ten years, we have tried to reflect the quality of nucleic acids from FFPET for prognostic and molecular diagnostic use. First, we developed a novel prognostic model using measurement of RNA expression in FFPET by quantitative real-time RT-PCR to predict the risk of distant metastasis of pN0-N1, hormone receptorpositive,
HER2-negative (HR+/HER2−) breast cancer patients. In this development, we applied novel FFPET-specific reference genes to calculate the relative mRNA expression levels of six prognostic genes and standardized mRNA expression value were reflected to its algorithm. Second, we established sample criteria for the minimum DNA quality from FFPET suitable for application to ddPCR-based EGFR mutation test and developed a novel follow-on companion diagnostics kit applying this sample criteria. In summary, the establishment of a robust standard for FFPET-derived nucleic acids would be the most critical
point in development of molecular diagnostics and this effort could contribute to mitigation of the molecular diagnostic risk.

Speaker
Biography:

Olorunfunmi is a Clinician working in Bingham University Teaching Hospital, Jos, Nigeria. His research interest is in maternal and child health, noncommunicable diseases and health policy development in developing countries.

Abstract:

Background: In developing countries such as Nigeria, anemia in pregnancy is thought to be commonest problem affecting pregnant women accounting for a significant level of maternal mortality.
Objectives & Method: This study was carried out to determine the prevalence of anemia in Pregnancy among Women Visiting Antenatal Clinic (ANC) in Bingham University Teaching Hospital (BHUTH). This is a cross sectional descriptive study conducted from 24th August to 28th September, 2015 on 237 women. A semi-structured interviewer-administered questionnaire was used to obtain socio-demographic, obstetric, nutritional and some hematological (blood group and genotype) information from the pregnant women who gave consent at each antenatal clinic day (Mondays and Thursdays). Packed Cell Volume was used to assess the level of anemia.
Result: The prevalence of anemia in pregnancy was found to be 43.5%. Amongst all women who were anemic, 83.9%, 8.7% and 2% were found to have mild, moderate and severe anemia respectively. Also, 0.9%, 35.9%, 52.4% of these women were found to be in their first, second and third trimesters respectively; 61.2% were multi-parous women (para 2-4); 24.3% women had only two antenatal clinic visits; 66.2% women had tertiary level of education; 99% women were married; 29.1% women were within the age group 34-39 years; 89.3% women had been taking balanced diet; 89.3% women were on their routine drugs; 66.0% women used insecticide treated net; 66.0% women had taken anti-malarial prophylaxis. Reduced ANC visits and increasing age where significant factors associated with anemia in pregnancy.
Conclusion: Prevalence of anemia amongst pregnant women in BHUTH was 43.5%. Commonest type of anemia in this study is mild anemia. Emphasis should be made on adequate nutrition and use of haematinics especially in late trimester as well as compliance with ANC visit among pregnant women in developing countries.

Speaker
Biography:

R C Jagessar has obtained his BSc in Chemistry from the University of Guyana in 1992 and pursued his PhD in the UK which he obtained in 1995. He did
Postdoctoral Research in the USA at the University of South Carolina, Wichita State University and later at the University of the West Indies, UWI. His research interests are broad, covering the spectrum of pure and applied chemistry, chemical biology, pharmaceutical and medicinal chemistry. He has won several international awards such as the Chartered Chemist, CChem of the Royal Society of Chemistry, Fellow of the Royal Society of Chemistry, FRSC, Royal Society Chemistry Research Grants etc. He has published 65 full peer reviewed papers, inclusive of four book chapters, exclusive of research abstracts, presented at conferences, both locally and internationally and has been a Reviewer of several international journals. He is currently working as a Lecturer of Chemistry in the Department of Chemistry, University of Guyana.

Abstract:

The aqueous and ethanolic extract of passion fruit (Passiflora edulis Sims) was investigated in the absence and presence of transition metal salts using the Disc Diffusion Assay under aseptic conditions. For the ethanolic extracts 1-3, the highest AZOI of 153.9 mm2 was induced by sample 1; 0.015 g/ml of extract against C. albicans. The lowest AZOI of 15.9 mm2 was also induced by sample 3; 0.1 g/ml of ethanolic extract against K. pneumoniae. There seems to be a general increase in AZOI as the concentration of ethanolic extract increases. From the ethanolic extract, a white isolate crystallized and its antimicrobial
activity was investigated at increasing concentration (sample 4-5). For sample 4-5, the highest AZOI of 149.5 mm2 was induced by the aqueous solution at a concentration of 0.026 g/ml against P. aeruginosa. The lowest AZOI of 30.7 mm2 was induced by the white isolate at a concentration of 0.052 g/ml against K. pneumoniae. For sample 6 and 7, 0.1g of Zn (OAc)2.2H2O in 10 ml aqueous extract and 1.0 g of Zn(OAc)2.2H2O in 10 ml of aqueous extract, it was observed that the highest AZOI of 67.2 mm2 was observed against E. coli, whereas, the lowest AZOI of 21.6 mm2 was observed against C. albicans. The AZOI induced by sample 8, 1.0 g of Zn (OAc)2.2H2O in 10 ml of aqueous solution is greater than sample 7, suggesting that Zn(OAc)2.2H2O augment the antimicrobial activity of the aqueous passion fruit extract. Antimicrobial selectivity was also observed. For example, against S. aureus, sample 1 exhibit AZOI of 32.2 mm2 whereas against C. albicans, AZOI of 153.9 mm2 was observed. For all experiments conducted, antimicrobial activity seems to be less than that of the standard antibiotics like Ampicillin and Nystatin. Nevertheless, the ethanolic and aqueous extracts of green passion fruit can be used as a natural antibiotic against a range of bacteria induced diseases.

Speaker
Biography:

Abstract:

Urtica dioica (Stinging Nettle) is one of the most popular plants, whose dietary and therapeutic benefits have been known since ancient times. The therapeutic activity of nettle leaves extracts in arthritis and osteoarthritis is related basically to the presence of phenolic compounds and their antioxidant activity. Literatures indicate that plants maturation leads to changes of their chemical composition. So firstly, we compared number of extracting methods to determine the one that gives the highest total content of phenolic compounds for which Folin-Ciocalteu method was applied. Secondly, the prepared soft extract was inserted in tablets and capsules formulations. Results showed that the optimal extracting method was in using fresh young leaves with ethanol 95% as extracting liquid at 70° C with reflux condenser, for five hours. We successfully developed the Urtica dioica herbal tablets using the wet granulation method. The best pharmaceutical formulation, contained calcium carbonate as filler, magnesium stearate and sodium benzoate as lubricants, sodium carboxy methyl cellulose (CMCNa) as disintegrating agent and alcoholic polyvinyl pyrolidone solution as binder. These granules formulation components were also successfully prepared to be filled later in hard capsules.

Speaker
Biography:

Hanaa A M Elgailany was graduated from College of Medical Laboratory Science (Microbiology) and has been awarded MSc degree in the same discipline. She is very enthusiastic, very competent and popular among her colleagues. She works as a Cooperator with Sudanese Red Crescent and other medical camps.

Abstract:

This was a descriptive and cross sectional study conducted from May to August 2015 to determine the antibacterial activity of Lawsonia inermis (Henna) leaves extract against Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa among recurrent urinary tract infection patients. A total of 100 urine samples were collected and inoculated on to Cystine Lactose Electrolyte Deficiency (CLED) media and identified by conventional method. 32 (32%) out of 100 investigated samples showed bacterial growth. Out of 32 isolated bacteria, 4 were Staphylococcus aureus (12.5%), 16 Escherichia coli (50%) and 3 Pseudomonas aeruginosa (9.4%). The reminder 9 (28%) were other bacteria. The antibiotic susceptibility testing was performed using standard disk diffusion method. The results showed that all S. aureus isolates were resistant to penicillin, 2 (50%) were susceptible to oxacillin while 2 (50%) were oxacillin resistance. Susceptible E. coli were 12 (75%), (88%) showed resistance to Nalidixic acid followed by Ceftriaxone (81%), Ciprofloxacin (75%) and Gentamicin (69%). P. aeruginosa susceptibility results showed high resistance to Nalidixic acid (100%) followed by Gentamicin (67%), Ceftriaxone (33%) and was susceptible to Ciprofloxacin. The antibacterial activity of Lawsonia inermis water and methanol leaves extract against selected organisms and standards was performed at different concentrations using the agar dilution method. Methanol extract of Lawsonia inermis showed antibacterial activity against S. aureus, S. aureus ATCC29213, E. coli, E. coli ATCC25922, P. aeruginosa and P. aeruginosa ATCC27853 also water extract showed antibacterial activity against all strains except E. coli and E. coli ATCC25922. The MIC of Henna methanol and water extracts obtained by agar diffusion method for S. aureus isolates were 12.5 mg/ml and 25 mg/ml, P. aeruginosa isolates were 6.25 mg/ml and 12.5 mg/ml respectively, E. coli isolates was 25 mg/ml in methanol but resistance to water extract. Gas chromatography analysis revealed that L. inermis has 51 chemical compounds, 30 of them have antibacterial activity

Anil Batta

GGS Medical College, India

Title: Biochemical diagnosis of acute pancreatitis

Time : 16:50-17:10

Speaker
Biography:

Anil Batta is presently a Professor and Senior Consultant in Baba Farid University of Health Sciences/GGS Medical College, India. He did his MBBS and MD in Medical Biochemistry from Government Medical College, Patiala in 1984 and 1991, respectively. His research interest is mainly in clinical application especially cancer and drug de-addiction. He has published more than 30 international research papers. He is the Chief Editor of American Journal of Biochemistry. He is also working as an Advisor to the Editorial Board of International Journal of Biological and Medical Research. Recently, he has been deputed advisor to Pakistan Medical Journal of Biochemistry.

Abstract:

The diagnosis of acute pancreatitis requires the presence of at least two of the three diagnostic criteria; characteristic abdominal pain, elevated serum amylase or lipase and radiological evidence of pancreatitis. Serum concentrations of
amylase and lipase rise within hours of the pancreatic injury. A threshold concentration 2-4 times the upper limit of normal is recommended for diagnosis. Serum lipase is now the preferred test due to its improved sensitivity, particularly in alcoholinduced pancreatitis. Its prolonged elevation creates a wider diagnostic window than amylase. Laboratory testing of serum amylase and/or lipase levels are central to the diagnosis of acute pancreatitis (AP) as these tests are quick, cheap, reliable and perhaps the only objective criteria available at the bedside at the time of initial presentation. It is important to understand the physiology and biochemistry of these tests in order to get a clear grasp of their diagnostic utility. Lipase is more specific than
amylase and stays elevated longer than amylase due to its longer half-life in serum resulting from renal tubular reabsorption. There is no advantage of testing lipase and amylase, as well as no advantage in serially trending them for monitoring the clinical progress of the patient. They have no role in determining the etiology or severity of acute pancreatitis. If the clinical suspicion for acute pancreatitis is high, imaging studies should be performed to confirm or rule out the diagnosis of acute pancreatitis even with low elevation or no elevation of these enzymes. This article is a comprehensive review of the existing literature on serum lipase and amylase as diagnostic tools for AP and their cut off levels used for the diagnosis of AP. Neither enzyme is useful in monitoring or predicting the severity of an episode of pancreatitis in adults. New biomarkers including trypsinogen and elastase have no significant advantage over amylase or lipase.

Speaker
Biography:

Lisette Perez Ojeda is a Professional in Pharmaceutical Sciences with 20 years of experience, 15 of them in the sector of Health Regulation of Medicines, focused mainly on the management of international cooperation from the National Regulatory Authorities, networking, project management, negotiation and implementation of agreements, the construction and monitoring of action plans, intellectual property and its linkage with access to medicines and other health technologies and the development and publication of scientific publications. She is also a Member of the Secretariat of the Regional Reference Regulatory Authorities.

Abstract:

The regulation and quality assurance of health technologies is a crucial element in the development of national pharmaceutical policies and the national regulatory authorities are responsible for implementing these actions; of its development and level of maturity will depend on the quality, safety and effectiveness of the medical products that are made available to the
populations. In the Americas region, since 2009, an evaluation and certification process has been developed that allows the designation of Regulatory Authorities of Regional Reference for medicines and biological products. To date, eight authorities have been certified and work together to achieve regulatory convergence through information exchange to streamline regulatory
decision-making and regional cooperation to promote development of other authorities in the region, actions that have a direct impact on access to effective health technologies of guaranteed quality. The networking work has allowed the development of an important group of cooperation activities towards other NRAs in the region for the development and strengthening of their regulatory capacities, as well as a mutual recognition work that allows timely access to health technologies such as safety, quality and effectiveness guaranteed.