4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials August 10-12, 2015 London, UK

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

Graeme Ladds, Director of PharSafer, has over 25 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. The last twelve years have been spent in his CRO company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections as well as working as full Pharmacovigilance & Medical Information provider for multi-national Companies.

Drug Safety & Medical Information

Peter (Director, Lanpharm Consulting) is a pharmacist with over 20 years experience in the pharmaceutical industry. Having graduated from Rhodes University in South Africa in 1995, he also holds a post-graduate certificate in Pharmacovigilance and Pharmacoepidemiology (London School of Hygiene and Tropical Medicine). Peter has 17 years experience in pharmacovigilance having gained experience within small and large pharmaceutical companies including Astra, GlaxoSmithKline, Gilead, Johnson & Johnson and AstraZeneca, as well as generic companies. With experience ranging from data entry of adverse events and case management, signal detection and evaluation, pharmacovigilance medical writing (including aggregate report production), risk management plan production and management, regulatory inspections and project management, Peter is perfectly placed to provide advice on most matters concerning pharmacovigilance.

Pharmacovigilance and Pharmacoepidemiology

Pharmacovigilance specialist with a PhD on hormonal regulation in an animal model and several years of experience in the generic and innovator industry. Manages pharmacovigilance systems for different clients and acts as QPPV for a number of them, creates safety data exchange agreements, ensures quality control and reporting compliance. Author of numerous scientific publications and safety reports on a variety of drugs and indications. Interested in the training of personnel, compliance monitoring, regulatory drug safety and quality assurance from clinical development for investigational to post-authorisation vigilance for (non-)marketed products. Proactive teamplayer with a high problem-solving capacity and good intersocial skills, cross-departmental expertise towards regulatory and clinical and non-clinical services. Management Team member of DADA, mother of two boys (happily married to their dad) and broadly interested in science and nature. Angela specialises in providing tailor made pharmacovigilance support, including QPPV provision and responsibility for the clients pharmacovigilance systems. Create safety data exchange agreements on behalf of our clients, database management of patient reports on adverse events related to medicinal product use, give training on basic and advanced pharmacovigilance, write periodic reports on the risk-benefit balance of pharmaceutical products by evaluating literature, case reports and all other relevant sources. Monitor the department for quality and compliance.

Benefit/Risk evaluation and management, Off label use and Medication errors

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

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

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

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

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

Ioan Magyar is 51 years old and works as an Associate Teaching Professor of Basic & Clinical Pharmacology at the Faculty of Medicine & Pharmacy, University Oradea, Romania. He has completed his PhD at the age of 41 with a thesis about “The pharmacological influences in acute myocardial infarction: the non-invasive evaluation of the efficiency of thrombolysis in STEMI patients”. Dr Magyar is the chief of the Department of Pharmacology at the previously mentioned university. He is involved in teaching as well as in clinical activities as an emergency medicine specialist. Holding the title of Consultant in Clinical Pharmacology and Emergency Medicine he attained a supplementary competence in Clinical Toxicology. His main research domain is Clinical Pharmacology and, in particular, the activity of Pharmacovigilance. In his professional bibliography a few post-doctoral studies may be found, under the coordination of the British Pharmacological Society. Among these ones we mention Enzymes as Drug Targets (London, 2011), Drug Discovery (London, 2012) and Clinical Discovery (London, 2012). Dr Magyar published over 65 scientific articles having the subject of Clinical Pharmacology as main theme. Some of those were published by Romanian medical journals, some in English language in medical journals of different countries. Since 2014 Dr Magyar has been invited to be member of the editorial board of the Journal of Clinical Pharmacology and Biopharmaceuticals, part of the OMICS group. Also this year, he has been invited and participated as Speaker/Expert at the Indo-Global Healthcare Summit & Expo, 20-22 June, Hyderabad, India.

Clinical Pharmacology

George Schroeder is a graduate of the University of Toronto, Faculty of Medicine, Toronto, Ontario, Canada, in addition to having earned a M.S. in Healthcare Management from the University of Texas School of Graduate Management ,affiliated with the South Western Medical School, Dallas, Texas. He is a member of the Beta Gama Sigma International Honor Society 2008. Currently he serves as Executive Director of Medical Affairs for the American Academy of Urgent Care Medicine, as well as a member of the Board of Directors of the American Board of Urgent Care Medicine. He is a Clinical Assistant Professor of Emergency Medicine at the University Of Central Florida College Of Medicine, in Orlando, Florida. He has published and lectured on Marine Toxins and Aquatic Hazards. He is President & CEO of Global Renaissance Enterprises Corp. He was appointed by the Governor of the State of Florida to the State Pharmaceutical & Therapeutics Committee in September 2009.He was also appointed member of the Board of Directors of the International Scientific Advisory Board of Magellan Bioscience in Tampa, Florida USA. Dr. Schroeder was appointed to the International Scientific Advisory Board ‎of the Magellan BioScience Group, LLC, as well as Chief Medical Officer for Magellan Pharmaceuticals, Inc. Tampa, Florida, USA

Healthcare Management