Conferenceseries Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry August 22-24, 2016 Vienna, Austria

Mario Bertazzoli is a physician and a registered specialist in Human Reproduction Pathology. He received both medical and specialization degrees from the University of Milan, Italy. He worked since 1995 for international pharmaceutical companies as pharmacovigilance and pharmaco-epidemiology physician. He is currently the Head of Corporate Drug Safety and Reference Physician to the EU Qualified Person for Pharmacovigilance for the Helsinn Group. He is founder and treasurer of the International Society of Pharmacovigilance, Swiss-Austrian Chapter.

Worldwide Pharmacovigilance (especially US, EU, Switzerland, China and Japan), Benefit-risk management and Pharmacoepidemiology.

Microbiology, Genetics, Immunology, Virology, Immunopharmacology, Cell Biology

Microbiology, Genetics, Immunology, Virology, Immunopharmacology, Cell Biology,

Saad Shakir qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then in the international pharmaceutical industry.He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine, a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the UK. He continues to practice clinical medicine part-time. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial board of the journals of Pharmacoepidemiology and Drug Safety. Saad Shakir has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Pharmacovigilance risk management and risk minimisation and its effectiveness

Kieran O’Donnell has over 15 years of PV and since 2006 has been leading European and Global PV operations, gaining broad experience in PV QMS; Benefit-risk management; Signal Detection & Management; PSURs & DSURs; RSI development; ICSR and SUSAR submission; Inspection (MHRA GCP & PV and FDA PV inspections; ISO 9001:2000; and responsible roles such as the RP for EudraVigilance and Deputy QPPV for Pharmacovigilance. In addition to his PgC Pharmacovigilance, he has been a member of the RQA PV Committee since 2008 and is a Fellow of PIPA. He joined TMC in June 2014.

Pharmacovigilance, EudraVigilance, Signal Detection, Benefit-risk management

1980 - 1994 Qualified University of London, Guy\\\\\\\'s Hospital Medical School followed by hospital medicine and clinical research: general medicine, 6 years in renal medicine, principal investigator in London, Birmingham, and Manchester attached to Renal Unit Royal Infirmary 1994 -1999 Senior Medical Assessor UK Medicines Control Agency – Senior Medical Assessor in Pharmacovigilance Assessment Group. 1999 - 2005 Senior Medical Director in a global CRO – Parexel Scientific and Medical Services – with responsibilities in pharmacovigilance and clinical trials. 2005 - 2007 Deputy Qualified Person for pharmacovigilance for Janssen Cilag Since July 2007, Dr Edwards has been a Principal Consultant in Pharmacovigilance and Drug Safety with NDA Regulatory Science Ltd based in Leatherhead, Surrey, UK. In addition, he chairs the QA panel overseeing the training of UK pharmaceutical physicians on behalf of the UK Faculty of Pharmaceutical Medicine and he is Director of ISoP Secretariat Ltd, is on the ISoP Executive Committee and is Treasurer as of November 2012. He is also Vice President in the Alliance Clinical Research Excellence and Safety (ACRES). He is co-chair of PharmaHUF in the UK & Ireland.

hospital medicine and clinical research: general medicine

Marco Manfredi MD, pediatrician and gastroenterologist, is now adjunct professor at Parma University. He carried out his education at Parma University where completed his PhD in Pediatric Gastroenterology in 2004. Currently he is working as Assistant Manager in Pediatric Gastroenterology at “Pietro Barilla” Children's Hospital in Parma, Italy. His main fields of interests are Helicobacter pylori infection, coeliac disease, gastrointestinal infectious diseases, functional gastrointestinal diseases, and Probiotics. Dr Manfredi published more than 75 papers, included chapters of textbooks. He is editor of three textbooks on “Helicobacter pylori infection”, “Gastrointestinal Endoscopy in Children” and on “Probiotics in Children” published by Nova Science Publishers, New York, USA. He is serving as an editorial board member of several reputed journal like “Clinical Microbiology: open access” and “Frontiers in Pediatric Gastroenterology and Hepatology” and expert Reviewer for journals like BMC Gastroenterology, Saudi Journal of Gastroenterology, BMC Case Reports. He is a member of Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition.

Gastroenterology, Hepatology and Nutrition

Dr Mahmud Kajbaf holds a Ph.D. from the University of London, King’s College, Biopharmacy department in the area of drug metabolism and MSc from Aston University, Birmingham. Dr Kajbaf is currently Senior Scientist at Aptuit and more than 23 years of industrial experience in drug discovery and development in various therapeutic areas especially in CNS field, with a particular focus on In vitro assay development and use of mass spectrometry in drug metabolism. He is serving as an editorial member of several reputed journals and also as expert reviewers for several Journals. He has authored 32 research articles in in vitro and in vivo drug metabolism and mass spectrometry.

In vitro Drug metabolism, In Vitro assay development , Mass spectrometry in drug metabolism.

Presently working she is a Professor, habilitated doctor, chemist, Chemistry & Biochemistry Discipline, Banat’s University of Agricultural Sciences and Veterinary Medicine “King Michael I of Romania” from Timisoara,300645, Calea Aradului 119, Timis, Romania, Teaching chemistry and biochemistry plant (specific disciplines). She Pursued Postdoctoral Studies on"Formulation and evaluation of dermato–cosmetic products" in the field of dermato-cosmetic sciences, chemical quality and toxicity of cosmetics, and galenics, formulation and efficacy of dermatologic or cosmetic, from "Victor Babes" University of Medicine and Pharmacy of Timisoara

Chemistry and Analytical Biochemistry; Research on natural compounds or active principles of plants; Develop approaches for the chemical characterization of medicinal plants and plant mixtures using different methods.Research Interests: Chemistry and Analytical Biochemistry; Research on natural compounds or active principles of plants; Develop approaches for the chemical characterization of medicinal plants and plant mixtures using different methods.

Dr. Damatarca has over 17 years of experience in the biopharmaceutical industry, across all stages of development and product commercialization. In her current position as Vice President of Medical Affairs and Pharmacovigilance at Agility Clinical, Dr. Damatarca provides oversight for all medical affairs and drug safety activities for Agility Clinical, which focuses on rare diseases.Before joining Agility Clinical, Dr. Damatarca was Vice President and Head of Drug Safety and Pharmacovigilance at Clovis Oncology, where she provided oversight for all safety aspects of the clinical development program for Clovis oncology molecules.Before that, Dr. Damatarca served as Executive Director and Head of Safety at Avanir Pharmaceuticals, where her responsibilities included oversight of clinical trials and postmarketing safety, pharmacovigilance, medical review, signal detection, aggregate reporting, and risk management. Previous functions included senior roles in Pharmacovigilance as Therapeutic Area Head for the Oncology Signaling Franchise at Genentech-Roche and before that, as Global Safety Officer and Global Safety Forum Chair at Amgen for various products in Oncology, Oncology–Hematology, and Inflammation-Internal Medicine. While at Amgen, she also served as the Chair of the Global Safety Forum, an internal advisory board for safety issues. Prior to Amgen, Dr. Damatarca worked in drug safety at several pharmaceutical companies. At Amylin Pharmaceuticals, she worked on products within the company’s product portfolio in the diabetes and metabolic disorders pipeline, most notably on two new molecular entities in diabetes. At Ligand Pharmaceuticals, she worked on several drugs in Oncology and Pain, and served as safety officer for various international clinical trials. During her tenure in drug safety and pharmacovigilance at various pharmaceutical companies, Dr. Damatarca participated in several Drug Advisory Committees and served on the teams who developed REMS - RiskMAP – risk management programs for various products, some of these having played a key role in optimizing the benefit-risk profile of the products.

Drug Safety and Pharmacovigilance

Dr Subodh Bhardwaj is a qualified Physician and Clinical pharmacologist with 3 decades of experience in the pharmaceutical Industry leading research and development of Vaccines and Biopharmaceuticals . Qualified MBBS from Medical College Jammu, India in 1981 and worked in Internal Medicine for 7 years, before qualifying MD Pharmacology from the prestigious AMU in India in 1990. He was associated with research on Hypertension, diabetes and trace elements till 1993.He joined as Medical Director of Serum Institute of India in 1993- the largest exporter of Vaccines globally and conducted research on Bacterial & Viral Vaccines- licensing DTPwHB, HB, Hib, DTPwHB Hib, MMR, MR, R, HDC Rabies Vaccines, Infertility drugs, Somatostatin, Somatropin & Onco BCG for Superficial Bladder Cancer as adjunctive therapy. His experience blends special skills in Pharmacovigilance of drugs & pharmaceuticals across broad therapeutic groups including Monoclonals for rabies. He has managed Pharmacovigilance, as Director Medical, Regulatory & Public Policy of Sanofi Pasteur India from 2008-2011 when notable products licensed were- Acellular Pentavalent IPV containing Vaccines, Pandemic and Seasonal Influenza Vaccines, Boosters, Yellow fever vaccine, Meningococcal vaccines among others. Well versed with Marketing and distribution of anticancers, Biologicals in Uganda as Director Medical Affairs Surgipharm Uganda & Rwanda from 2013-2015. Leading Clinical research & Pharmacovigilance in Vaccines& Pharma- he has organized large sample size trials from Preclinical to licensure and Post Marketing Surveillance in India and abroad. He is Member of BRAPP, European Society of Pharmacovigilance, with 60 National & International publications in reputed journals. He currently works as Biopharmaceutical Consultant & Vice President Arable Corporation besides consulting for International organizations on topics of Public health importance.

Pharmacovigilance, Clinical research, Influenza Vaccines, Viral Vaccines, Meningococcal vaccines, Yellow fever vaccine

Dr J Vijay Venkatraman is a Diabetologist, Drug Safety Physician and Entrepreneur, with an overall experience of 14 years, of which the last 8 years have been in the Pharmacovigilance industry. He holds a MBA degree in Services Management and has been awarded the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association, United Kingdom. Dr Vijay is the Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research, for 2015-17. He is an Affiliate Member of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom. Dr Vijay founded Oviya MedSafe, a global Pharmacovigilance Consulting & Drug Safety Services company incorporated in Coimbatore, India in 2012 and London, UK in 2014, which has been catering to the international as well as the Indian pharmaceutical industry ever since its inception. Dr Vijay is an invited speaker in national and international conferences on Drug Safety as well as Diabetology. He has published in many national & international journals and magazines. He is actively involved in promoting pharmacovigilance awareness among doctors. Dr Vijay has been associated with various institutes as a Pharmacovigilance Trainer. He is also a practising Diabetologist at Diab-at-ease Clinik, KTVR Group Hospital, Coimbatore.

Diabetologist and Drug Safety

He has completed his education Mysore Medical College, India. He pursued his Fellowship , Neonatal-Perinatal Medicine at Baylor College of Medicine and post graduation in Pediatrics at Newark Beth Israel Medical Center. He is a fellow member of American Academy of Pediatrics (Perinatal Pediatrics). He also had membership in Southern Society for Pediatric Research and Texas Pediatric Society.

Neonatal-Perinatal Medicine, Pediatrics, Role of aryl hydrocarbon receptor in hyperoxic lung injury in newborn mice and human neonatal lung derived cells.

Mohamed Eddouks is Professor at Moulay Ismail University, Faculty of Sciences and Techniques Errachidia, Morocco. He is a researcher in Physiology and Pharmacology with a Master Degree in Metabolic and Molecular Endocrinology from University of Paris vi, a specialized certificate in Endocrine Pharmacology from University of Paris vii and PhD degrees in Physiology and Pharmacology from University of Liege, Belgium and Sidi Mohammed Ben Abdellah University, Fez, Morocco. After his post-doctoral fellowship at Department of Physiology, Faculty of Medicine of Montreal, Canada, he is working for the last 13 years on medicinal plants. His work on antidiabetic and antihypertensive plants is well recognized globally. His research focuses on ethnobiological as well as pharmacological issues in the use of Moroccan medicinal plants for the treatment of diabetes mellitus, obesity and hypertension. His contribution to this field includes three international books and more than 80 peer-reviewed articles and book chapters of international repute. He is Guest Editor of American Journal of Pharmacology and Toxicology, Lead Guest Editor of an annual special issue published by Evidence-Based and Complementary Alternative Medicine, Regional Editor of the Following journals: American Journal of Food Technology, Journal of Applied Sciences, Trends in Applied Sciences Research and Singapore Journal of Scientific research, Member of Editorial Board of several international journals. He has been honored with the first Prize of Scientific Research in 2008 by the Moroccan Association of Research and Development. He has been the Dean of Polydisciplinary Faculty of Errachidia from 2008 to 2012.

Pharmacology, Ethnopharmacology, Phytotherapy, Pharmacognosy, Phytochemistry, Toxicology, Diabetes, Hypertension, Obesity and Medicinal Plants.

Dr. Michael Forstner is Managing Partner and Head of Risk Management and Business Process Management Practice at Mesama Consulting International, where his main focus areas are the planning, development, implementation and evaluation of (benefit-)risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development and implementation of additional risk minimization and PV measures in the context of RMPs. Before entering into his current role, Dr. Forstner was Head of Regional Pharmacovigilance Europe at Boehringer-Ingelheim. His main focus at BI had been to establish a proactive and highly integrated benefit-risk management organization with strong links to other functions, while maintaining compliance with all local regulations in the 35 countries of his region. From 2009 to 2013, he was Process Development Leader in Drug Safety and Chair of the global Risk Management Working Group at Roche, Basel, where he was – amongst other duties – responsible for all aspects of global benefit-risk management planning and implementation of RMPs. Prior to this he worked in a variety of positions in pharmaceutical R&D at Pharmacia (Nerviano, Italy) and Novartis (Basel, Switzerland), focusing mostly on signal transduction pathways in oncology and CNS disorders, and in drug liability risk management at Zurich Financial Services. He studied biochemistry and medicine in Graz, Austria, holds a PhD in biochemistry from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland, did postdoctoral work at UC Berkeley/Lawrence Livermore National Laboratory, California in the area of structural enzymology and biophysics, and was Assistant Professor of Molecular Structural Biology at Sveriges Lantbruksuniversitetet in Uppsala, Sweden. Recently he also obtained a postgraduate certificate in Pharmacovigilance and Pharmacoepidemiology from the London School of Hygiene and Tropical Medicine. In his spare time, Michael loves to spend time outdoors with his children and dogs and to engage in various activities from skiing and hiking, to fishing, hunting, horseback riding and gardening. He is also an avid reader, and loves the opera and music in general.

planning, development, implementation and evaluation of (benefit-)risk management solutions

Shelley has extensive knowledge of all European regulatory processes related to monitoring the safety of licensed medicinal products and ancillary devices and has investigated possible risks and has taken appropriate actions to minimise risk to public health through both European and National Committees. Most recently Shelley was the project lead with regards to ensuring the MHRA complies with the new Pharmacovigilance legislation which came into force on 2 July 2012 and before that she was Vigilance and Intelligence Research Group Unit Manager where she led a team of 30 whose primary role is to carry out risk assessment.

European regulatory processes,safety of licensed medicinal products.

Dr. Pipasha Biswas is currently Executive Director & QPPV of Symogen Ltd, UK, an international service provider in Pharmacovigilance, Pharmacoepidemiology, Medical Writing and Regulatory Affairs worldwide. She has been involved in pharmacovigilance for the last 20 years in Europe, USA and India. She has worked in a number of MNCs in Pharmacovigilance as Executive Director and Lead for Safety Signal detection at Global Drug Safety at Amgen Inc based in California, where she lead the safety signal detection team in global safety. In the UK, she worked as Director, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance at GSK, where she was the lead physician responsible for Respiratory and Anti-inflammatory therapeutic area. Prior to working at GSK, London, she was EU Senior Pharmacovigilance Physician at the European Office of Global Safety Surveillance and Epidemiology at Wyeth Europa, based in the UK. Before moving to the pharmaceutical industry, she was Clinical Research Fellow at the Drug Safety Research Unit, based in Southampton, where she conducted large studies in post marketing surveillance, pharmacoepidemiology and signal detection activities. She also has considerable experience in Clinical Research and Clinical Drug Development, having worked at the Department of Vascular Medicine, King’s College of Medicine & Dentistry, where she was responsible for conducting clinical trials in Deep Vein Thrombosis patients from phase II to III. She qualified in Medicine from India and trained in Internal Medicine & Cardiology and did her post graduation in Pharmaceutical Medicine, from University of Surrey, UK. She then specialized in Pharmacovigilance & Pharmacoepidemiology from London School of Hygiene and Tropical Medicine, London and then did her DM in Pharmacoepidemiology from University of Southampton, UK. She is the Member of British Association of Regulatory and Quality Assurance (BARQA), International Society of Pharmacovigilance (ISOP) and International Society of Pharmacoepidemiology (ISPE). She has been conferred with the Membership of The Faculty of Pharmaceutical Medicine (Distinction), UK from The Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London. She is the Director of Continuing Professional Development (CPD) at the Faculty of Pharmaceutical Medicine, Member, Professional Standards Committee and International Committee at the Faculty of Pharmaceutical Medicine of The Royal College of Physicians, London. She is the Chairperson, for Pharmacovigilance & Drug Safety Consultative Committee at The Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London, UK.

Pharmacovigilance, Pharmacoepidemiology, Medical Writing and Regulatory Affairs

Mohamed Eddouks is Professor at Moulay Ismail University, Faculty of Sciences and Techniques Errachidia, Morocco. He is a researcher in Physiology and Pharmacology with a Master Degree in Metabolic and Molecular Endocrinology from University of Paris vi, a specialized certificate in Endocrine Pharmacology from University of Paris vii and PhD degrees in Physiology and Pharmacology from University of Liege, Belgium and Sidi Mohammed Ben Abdellah University, Fez, Morocco. After his post-doctoral fellowship at Department of Physiology, Faculty of Medicine of Montreal, Canada, he is working for the last 13 years on medicinal plants. His work on antidiabetic and antihypertensive plants is well recognized globally. His research focuses on ethnobiological as well as pharmacological issues in the use of Moroccan medicinal plants for the treatment of diabetes mellitus, obesity and hypertension. His contribution to this field includes three international books and more than 80 peer-reviewed articles and book chapters of international repute. He is Guest Editor of American Journal of Pharmacology and Toxicology, Lead Guest Editor of an annual special issue published by Evidence-Based and Complementary Alternative Medicine, Regional Editor of the Following journals: American Journal of Food Technology, Journal of Applied Sciences, Trends in Applied Sciences Research and Singapore Journal of Scientific research, Member of Editorial Board of several international journals. He has been honored with the first Prize of Scientific Research in 2008 by the Moroccan Association of Research and Development. He has been the Dean of Polydisciplinary Faculty of Errachidia from 2008 to 2012.

Pharmacology, Ethnopharmacology, Phytotherapy, Pharmacognosy, Phytochemistry, Toxicology, Diabetes, Hypertension, Obesity and Medicinal Plants.