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Postmarketing Safety Studies: Approaches and Regulatory Insights
Session Chair(s)
Elsie Grace, PHD, MS
Senior Director, Global Patient Safety, Pharmacoepidemiology, Eli Lilly and Company, United States
We are seeing an increase globally in the number of postmarketing safety studies requested by regulatory agencies. This session will discuss approaches to planning and conducting observational postmarketing studies, regulatory perspectives on such studies and a case example.
Learning Objective : Discuss approaches to postmarketing safety studies and the ways in which they can have impact and provide value.
Speaker(s)
Take-Home Learnings on Do’s and Dont’s on the Planning and Conduct of a PASS
Research Scientist, Evidera, Spain
How to Maximize the Impact of Postmarketing Research: Considerations for Effective Execution and Compliance
Senior Corporate Counsel, Cogent Biosciences, Inc., United States
An Innovative Patient-Centric Approach to Conducting Postmarketing Safety Studies
Senior Research Scientist, PPD, part of Thermo Fisher Scientific, United States
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