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Complimentary - What to Learn from US FDA Warning Letters and Their Impact on Pharmacovigilance Operations

Presenters

Mitchell S. Gandelman, MD, PhD

Mitchell S. Gandelman, MD, PhD

Principal, Global Consultancy Services, Safety and Risk Management, Sciformix Corporation, United States

Mitch is presently employed at Sciformix as a Principal in the Global Consultancy Services, Safety and Risk Management. Mitch spent 20 years in the pharmaceutical industry, mostly in pharmacovigilance (PV), but has experience in Medical Affairs and International Development. Most of Mitch’s career in the industry was at Pfizer, but he also worked at Johnson and Johnson and Alexion Pharmaceuticals. Mitch held positions of Vice President, Global Safety and Risk Management for Pfizer, Vice President of PV Analytics and Insight at Johnson & Johnson, and finally as Vice President of PV at Alexion Pharmaceuticals. Mitch is also a practicing psychiatrist.

David J. Balderson, PhD

David J. Balderson, PhD

VP Global Safety Operations, Covance, United States

Worked in Pharmacovigilance for over 17 years, initially at GSK in the UK, followed by nine years at Amgen in the US including roles as Head of Safety Operations and Head of Regulatory Operations prior to joining Sciformix in 2015. Managed significant global changes in safety processes to improve overall business efficiency including the development of an electronic interface for serious adverse event collection in clinical trials and the implementation of a new safety system. Experienced in developing flexible business models while ensuring compliance and quality delivery.

JP  Clement, MD

JP Clement, MD

Founder and Principal, JPCC Associates, United States

Dr. Clement is an Executive PV Consultant for the pharmaceutical industry. He has worked in Drug Safety and Pharmacovigilance in multiple capacities, mostly with global responsibilities. In his last role, he was leading the PV activities for Cubist (now part of Merck) as Vice-President, Global Pharmacovigilance & Medical Risk Management. In his extensive experience, he has held senior positions for Drug Safety and Pharmacovigilance at Onyx/Amgen, Janssen, Sanofi, Lipha-Merck Kga, Abbott and Janssen France.

Deepa  Arora, MD

Deepa Arora, MD

Vice President and Global Head - Drug Safety and Risk Management, Lupin Limited, India

Dr. Deepa Arora is Vice President- Pharmacovigilance & Global Head- Drug Safety & Risk Management with Lupin Limited. She is a Physician with more than 15 years of experience in drug safety and clinical development in pharma industry and academia. She has successfully set up world class Pharmacovigilance systems for Lupin & Lupin subsidiaries in US, Europe, Japan and Australia. Under her able leadership, Lupin has successfully cleared Pharmacovigilance inspections conducted by regulatory authorities across the world.

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