返回 Agenda
Counting on Safety
Session Chair(s)
William Wang, PHD
Executive Director
Merck & Co, Inc, United States
The regulatory landscape for safety monitoring is evolving, particularly in emerging regulation/guidance from the US FDA and EMA. This maturing regulatory landscape calls for a systematic and proactive process, multi-disciplinary collaboration, quantitative framework/methods/tools, built on a solid safety data architecture. This session will feature presentations on global safety monitoring regulations and the relevant clinical and statistical considerations. The FDA IND safety reporting final rule will be reviewed (FDA speaker invited). The design consideration to align with the recent guidance of the FDA IND safety reporting final rule will be shared by an industry representative.
Learning Objective : Discuss the latest regulatory landscape for safety monitoring.
Speaker(s)
IND Safety Reporting
Stephanie Shapley, MBA
FDA, United States
Associate Director for Regulatory Affairs, OMPI, OMP, CDER
Safety Assessment Committees: More Than One Way to Navigate the Pharmacovigilance Seas
Barbara Hendrickson, DrMed, MD
United States
Clinical Associate, Pediatric Infectious Diseases
Systems Theoretic Process Analysis : A New Way to Strengthen Pharmacovigilance Processes - A Case Study
Alan Hochberg
Genentech, A Member of the Roche Group, United States
Principal Scientific Enablement Director, Scientific Enablement and Processes