10:40 a.m.-12:10  p.m.    Pharmaceutical Safety


 

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

 

  10:4011:10

 

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

 

  11:1011:40

 

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

 

  11:4012:10

 

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
 

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