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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)
Panelist
Susan Talbot, MSc
Amgen, United States
Director Biostatistics
Panelist
Ranjeeta Sinvhal, MD
AbbVie, United States
Executive Medical Director, Medical Safety
Panelist
Susan Kindig, JD, MD
United States
Prior Executive Director, Medical and Drug Safety
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