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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
Javier Cid, DrPH, MD, MBA, MSC
Evidera, Spain
Research Scientist
How to Maximize the Impact of Postmarketing Research: Considerations for Effective Execution and Compliance
Aarthi Iyer, JD, MPH
Cogent Biosciences, Inc., United States
Senior Corporate Counsel
An Innovative Patient-Centric Approach to Conducting Postmarketing Safety Studies
Deborah Covington, DrPH
PPD, part of Thermo Fisher Scientific, United States
Senior Research Scientist