×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
Generic Drug Products: Comparison of Safety Profile With Branded Cousin
Session Chair(s)
Howard Chazin, MD, MBA
Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER
FDA, United States
This forum will discuss how FDA interprets generic drug regulation and safety reporting requirements along with review practices, ethics considerations, and guidance and labeling development to monitor and ensure generic drug safety.
Learning Objective : Summarize how pre- and post-market elements of generic drug safety and surveillance integrate understanding of critical clinical elements of performance; Compare risk/benefit considerations for patients versus healthy volunteers in bioequivalence (BE) studies and effects on enrollment criteria and safety monitoring.
Speaker(s)
FDA Perspective
Howard Chazin, MD, MBA
FDA, United States
Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER
Academic Perspective
Aaron Kesselheim, JD, MD, MPH
Brigham and Women's Hospital/Harvard Medical School, United States
Associate Professor of Medicine
Industry Perspective
Kiran Krishnan, PhD
Apotex Inc, United States
Senior Vice President, Global Regulatory Affairs
Have an account?