From the Agenda

Challenges of Signal Detection in Biosimilars

2016-11-23 16:30:00

Dr Pipasha Biswas

Vice President, Pharmacovigilance/pharmacoepidemiology & Late Phase RWE

Dr. Pipasha Biswas is currently Executive Director & QPPV of Symogen, 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 Medical 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 Medical Director, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance at GSK, where she was the lead physician responsible for Respiratory and Antiinflammatory 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 MD in Medicine and 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.