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, Se
|SOURCE United BioSource Corporation|
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