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Tuesday, June 26 • 8:00am - 9:15am
#201: Generic Drug Products: Comparison of Safety Profile With Branded Cousin

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-554-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Howard Chazin


FDA Perspective
Howard Chazin

Academic Perspective
Aaron Kesselheim, JD, MD, MPH

Industry Perspective
Kiran Krishnan, PhD

avatar for Howard Chazin

Howard Chazin

Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER, FDA, United States
Dr. Chazin joined FDA in 2002 and has held several leadership positions related to clinical policy and safety of new drugs, biologics and generics. He is the Director of the Division of Clinical Safety and Surveillance in the Office of Generic Drugs' Office of Safety and Clinical... Read More →

Aaron Kesselheim

Associate Professor of Medicine, Brigham and Women's Hospital/Harvard Medical School
Dr. Kesselheim is an internist, lawyer, and faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Within the Division, Aaron created and leads the Program On Regulation, Therapeutics, And Law (www.PORTALresearch.org), an interdisciplinary... Read More →

Kiran Krishnan

Senior Vice President, Global Regulatory Affairs, Apotex Inc
Kiran Krishnan is Senior Vice President, Global Regulatory Affairs at Apotex Corp., located in Weston, Florida. He has 18 years of experience in the generic pharmaceutical industry. Kiran's areas of expertise include formulation development, process development, validation, intellectual... Read More →

Tuesday June 26, 2018 8:00am - 9:15am EDT
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Forum