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

Conference: How to Build Effective Global Programs Required by New Legislation

BETHESDA, Md., Nov. 19 /PRNewswire/ -- United BioSource Corporation's (UBC) Annette Stemhagen, DrPH, FISPE, and Gerald Faich, MD, MPH, FISPE, addressed the Risk Management and Drug Safety Summit held in Washington, DC, on October 28 and 29, along with Janet Woodcock, MD, Director, CDER, FDA; Jane Axelrad, Associate Director for Policy, CDER, FDA; Claudia Karwoski, acting director, Division of Risk Management Team, Office of Surveillance and Epidemiology, CDER; and other leading scientists from the pharmaceutical community.


Co-sponsored by UBC and FDA News, the two-day conference was designed to help drug and biologics manufacturers understand how to build effective global risk management and drug safety programs, in response to the FDA Amendments Act of 2007 (FDAAA) and new international regulations now under development.

Patrick Lindsay, UBC's Executive Vice President, said "UBC was pleased to join forces with FDA News to bring together this esteemed group of experts in risk management. We recognize how important it is to master the critical components of the FDAAA to optimize pharmaceutical products, both for the safety of patients and to create value for pharma and biotech companies."

Dr. Stemhagen, Vice President, Epidemiology and Risk Management, UBC, spoke about "Using Registries and Large Streamlined Studies (LSS) to Improve Post-Approval Safety Surveillance, Risk Assessment and Risk Management," reviewing key factors to consider before implementing a registry or LSSs, best practices for using registries as part of risk management planning, and real-world case studies using LSSs.

Dr. Faich, Senior 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 us to assist with REMS."

United BioSource Corporation (UBC) is a global pharmaceutical services organization that helps emerging and established life science companies develop and commercialize medical products. UBC specializes in offering new and innovative ways to study drugs and devices by providing expertise in science, strategy and execution.

UBC is headquartered in Bethesda, Maryland, with offices in the United States, Canada, Western Europe, Eastern Europe and South America. For more information, visit or call 866-458-1096.

CONTACT: Tess Drahzal, +1 (240) 644-0420,

SOURCE United BioSource Corporation
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