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Drug Information Association
Annual Meeting - San Diego
June 2000
Assessing Quality of the Regulatory Review
Function
Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research,
US Food and Drug Administration (6/22/2000)
CERTs and the FDA Implementation of FDAMA 409,
Peter K Honig, MD, MPH (7/3/2000)
E-Environment at the FDA, Ralph Lillie,
Office of Information Technology (6/22/2000)
Electronic ICSRs: The US Pilot, Deborah
Yaplee, OPDRA (6/29/2000)
Expedited Development and Review Iniatives
- FDA Perspective
Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research,
US Food and Drug Administration (6/22/2000)
Integrating Pediatric Studies into Drug
Development Regulatory Perspectives, Victor Raczkowski (7/25/2000)
Patient Misuse and Investigator Fraud in
Clinical Trials: What Can Be Done? Part I, Stan W. Woollen, Deputy Director, Division
of Scientific Investigations, Center for Drug Evaluation and Research, FDA (6/27/2000)
Periodic Safety Updates: Opportunities and
Challenges - A U.S. Perspective, Peter K Honig, MD, MPH (7/3/2000)
Safety Reporting: FDA’s Perspective,
Nancy Haggard, MPH (8/8/2000)
Update from the Office of Postmarketing Drug
Risk Assessment (7/3/2000)
Update on FACA and CDER’s Advisory
Committees
Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research,
US Food and Drug Administration (6/22/2000)
Update on FDA’s Pediatric Labeling
Regulations and Initiatives on Patient Drug Information, Victor Raczkowski (7/25/2000)
Who’s in Charge Anyway? Responsibility
in Today’s Clinical Trial Environment, Stan W. Woollen, Deputy Director, Division
of Scientific Investigations, Center for Drug Evaluation and Research, FDA (6/27/2000)
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FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DLIS
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