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Session 12: Implementation of Safety Surveillance Plans Roundtables
Session Chair(s)
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States
This session will focus on the logistics of implementing the Safety Surveillance Plan (SSP) described in FDA’s June 2021 Draft Guidance, Sponsor Responsibilities— Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.
After a brief introduction of the topic, participants will be divided into separate groups with a facilitator and discussion prompts. Participants will be asked to converse about how the various components of the FDA’s suggested SSP are best implemented. After a period of time, the participants will come back together and share the insights from their table discussion.
Learning Objective : - Describe the components of FDA’s suggested Safety Surveillance Plan per their June 2021 Draft Guidance
- Appraise different approaches to implementing a Safety Surveillance Plan
- Identify challenges in execution of the Safety Surveillance Plan and potential ways to overcome
Speaker(s)
Speaker
Cynthia McShea, MPH
UCB Biosciences, United States
Head, Safety Statistics
Speaker
Greg Ball, PhD
ASAPprocess, United States
Safety Data Scientist
Speaker
Ranjeeta Sinvhal, MD
AbbVie, United States
Executive Medical Director, Medical Safety
Speaker
Evgeny Zalmover
Boehringer-Ingelheim Pharmaceuticals, Inc., United States
Executive Director, Medical Safety, Oncology, Patient Safety and Pharmacovigilan