10:40 a.m.-12:10 p.m. Pharmaceutical Safety
Organizer: Yu-Te Wu (Food and Drug Administration, U.S.A.) Email: YU-TE.WU@fda.hhs.gov Chair: Yu-Te Wu (Food and Drug Administration, U.S.A.) Email: YU-TE.WU@fda.hhs.gov
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10:40-11:10
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Speakers: Min-Hui Chen Center for Drug Evaluation, Taiwan, R.O.C. Email: mhchen@cde.org.tw Title: Drug-Induced Liver Injury: Clinical Summary and Premarketing Evaluation
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11:10-11:40
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Zili Li Merck Phamaceuticals, U.S.A. Email: zili_li@merck.com Title: Use of Data Pooling in Drug Risk Assessment at US FDA - A Clinical Perspective
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11:40-12:10
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Yu-Te Wu Food and Drug Administration, U.S.A. Email: YU-TE.WU@fda.hhs.gov
Title:
Detecting Rare Adverse Events in
Post-Marketing Safety Studies: Statistical Considerations |