Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
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Organizing Committee:
Yi Huang (UMBC)
Nagaraj Neerchal (UMBC)
Bimal Sinha (UMBC)
Tze Lai (Stanford)
Phillip Lavori (Stanford)
Ying Lu (Stanford)
Jie Chen (Novartis)
Joseph Heyse (Merck)
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Mark Levenson from FDA.
Paper: Ongoing Efforts in Quantitative Drug Safety Assessment at FDA/CDER
In the last 10 years, several internal and external events, initiatives, and actions have increased the resources and efforts devoted to the evaluation of drug safety in both the premarket and post-market life-cycles of drugs at the Center for Drug Evaluation and Research (CDER). Biostatistics at CDER has had a large role in these efforts. Biostatistics support in quantitative drug safety has included the design and analysis of (1) large outcome trials, (2) meta-analyses, and (3) observational studies. The talk will present examples in these areas and future directions and challenges in the area of quantitative drug safety.