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A Safety Surveillance Plan for Serious Anticipated Events
Session Chair(s)
Greg Ball, PHD
Safety Data Scientist, ASAPprocess, United States
A number of questions remain about Safety Surveillance Plans (SSPs). The proposed panel discussion will include persons from multiple sponsors who have experience with developing processes to address the FDA’s recommendations in the 2021 guidance.
Learning Objective : Discuss when a safety surveillance plan (SSP) is warranted; Describe specifics on implementation of the trigger method; Evaluate a product in different patient populations and ensure study integrity; Identify clarity on roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting.
Speaker(s)
Susan Talbot, MSC
Director Biostatistics, Amgen, United States
Panelist
Ranjeeta Sinvhal, MD
Executive Medical Director, Medical Safety, AbbVie, United States
Panelist
Susan Kindig, JD, MD
Prior Executive Director, Medical and Drug Safety, United States
Panelist
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