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
Simone Pinheiro from U.S. Food and Drug Administration.
Paper: Challenges and Opportunities in Post-Market Drug Safety Evaluation from a Regulatory Perspective
Post-market evaluation of drug safety at the Food and Drug Administration involves consideration of various sources of evidence oftentimes beyond clinical trial data, including those relying on observational data. This presentation will discuss the current process and resources involved in the post-market evaluation of drug safety, with focus on important challenges and opportunities in post-market drug safety evaluation from a regulatory perspective