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Tuesday, June 29 • 10:00am - 11:00am
#220 L: Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-569-L04-P; CME 1.00; IACET 1.00; RN 1.00

Hear from leadership in FDA's Office of Generic Drugs and Office of Pharmaceutical Quality about key priorities and topics of interest for generic drug development.

Learning Objectives

Identify top policy issues for generic drug development; Discuss quality and inspectional challenges for generic pharmaceutical products; Identify regulatory issues and opportunities specific to complex generics.

Chair

Rachel Turow, JD, MPH

Speaker

Panelist
William Chong, MD

Panelist
Lei Zhang, PhD

Panelist
Lisa Bercu, Esq, JD

Panelist
Ashley Boam, MS

Panelist
Susan Rosencrance, PhD

Panelist
Stelios Tsinontides, PhD, MA


Speakers
avatar for Rachel Turow

Rachel Turow

Associate General Counsel, Regulatory Law and Policy; Head, US Regulatory Policy, Teva Pharmaceutical Industries Ltd., United States
Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination... Read More →
avatar for Lisa Bercu

Lisa Bercu

Regulatory Counsel, Office of Generic Drug Policy, FDA, United States
Lisa Bercu is a regulatory counsel in the Office of Generic Drug Policy, Office of Generic Drugs (OGD) where she focuses on policy development for combination products. Before joining OGD in October 2016, Ms. Bercu worked at a medical society providing strategic advice on issues including... Read More →
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... Read More →
avatar for William Chong

William Chong

Associate Director for Clinical Affairs, Office of Generic Drugs, CDER, FDA, United States
Dr. William Chong is an Internist and Endocrinologist who has worked at FDA since 2012. He is currently the Associate Director for Clinical Affairs in the Office of Generic Drugs and lends support to the generic drugs program across an array of activities in order to provide safe... Read More →
avatar for Susan Rosencrance

Susan Rosencrance

Acting Director, Office of Generic Drugs, CDER, FDA, United States
Susan Rosencrance, Ph.D., serves as the Acting Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). From 2015 to 2022, Dr. Rosencrance served as the Director of the Office of Lifecycle Drug Products within CDER’s Office of Pharmaceutical... Read More →
avatar for Stelios Tsinontides

Stelios Tsinontides

Office Director, OPMA, OPQ, CDER, FDA, United States
Dr. Stelios Tsinontides is the Office Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA). OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at... Read More →
LZ

Lei Zhang

Deputy Director, Office of Research & Standards, Office of Generic Drugs, CDER, FDA, United States
Dr. Lei Zhang is Deputy Director of the Office of Research and Standards within the Office of Generic Drugs in CDER, FDA. She is an accomplished professional with more than 22 years of combined experiences in the areas of drug research, development and regulatory review and approval... Read More →

Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Forum |   09: Regulatory, Forum