United BioSource Scientists, FDA, and Other Industry Leaders Present to Risk Management and Drug Saf... (nior Vice President Epidemiology and Ris...)

United BioSource Scientists, FDA, and Other Industry Leaders Present to Risk Management and Drug Safety Summit

Date:11/19/2008

nior Vice President, Epidemiology and Risk Management, UBC, co-moderated a session called "How Does the FDA Intend to Evaluate REMS (Risk Evaluation Mitigation Strategy)?" with Dr. Stemhagen and other industry leaders. This session evaluated how FDA's response to previously submitted REMS provides insight into how to create successful and compliant REMS.

Other speakers included:

Laurent Auclert, MD, Head, Risk Management Plan Unit, Global Pharmacovigilance & Epidemiology, sanofi-aventis

Cherif Benatti, MD, Vice President, Pharmacovigilance & Public Health, Vertex Pharmaceuticals

Carmen Bozic, Vice President, Drug Safety & Risk Management, Biogen Idec

John Ferguson, Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics

Joanna Haas, MD, MS, Vice President, Pharmacovigilance, Genzyme Corporation

Peter Pitts, Co-founder and President of Center for Medicine in the Public Interest and Senior Vice President, Health Affairs, Manning, Selvage & Lee

Donald Therasse, MD, Vice President, Global Patient Safety, Lilly Research Laboratories

"All conference presenters were mindful of the pressure on drug and biologics manufacturers in light of FDAAA's passage in late March 2007," noted Dr. Stemhagen. "Since then, FDA has mandated REMS for 31% of all new molecular entities and novel therapeutic biologics. In just the past seven months, we at UBC have seen a dramatic increase in the number of clients who have asked u
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