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Tuesday, June 21 • 4:15pm - 5:15pm
#266: FDA's Updates on Ensuring Post Market Safety and Surveillance for Generic Drugs

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-579-L04-P ; CME 1.00; RN 1.00

This forum will discuss how FDA, industry, and academia engage in generic drug safety evaluations; provides new options for REMS; and pilots use of emerging tools and technologies to monitor and ensure generic drug safety and substitutability.

Learning Objectives

Review how pharmacovigilance (through FDA, industry and academic perspectives) ensures the continued safety and therapeutic equivalence of generic drugs; Describe options for risk evaluation and mitigation strategies for generic drugs; Explore use of data analytic tools/technologies that ensure continued safety and therapeutic equivalence of generic drugs.


Howard Chazin, MD, MBA


Moderator: Industry Perspective
Jamie Wilkins, PharmD

FDA's Perspective
Howard Chazin, MD, MBA

Academic Perspective
Joseph Ross, MD, MHS

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 →
avatar for Joseph Ross

Joseph Ross

Professor of Medicine and Public Health, Yale University School of Medicine, United States
Joseph S. Ross, MD, MHS, is a Professor of Medicine (General Medicine) and of Public Health (Health Policy and Management) at the Yale School of Medicine, an Associate Physician of the Center for Outcomes Research and Evaluation at Yale-New Haven Health System, and Co-Director of... Read More →
avatar for Jamie Wilkins

Jamie Wilkins

Senior Director, Head - Risk Management Center of Excellence-Worldwide Safety, Pfizer Inc, United States
Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum