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DIA 2021 Global Annual Meeting

Office of Generic Drugs and Office of Pharmaceutical Quality Generics Town Hall

Session Chair(s)

Rachel Turow, JD, MPH

Rachel Turow, JD, MPH

  • Associate General Counsel, Regulatory Law & Policy; Head, U.S. Regulatory Policy
  • Teva Pharmaceutical Industries Ltd., United States
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 Objective : 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.

Speaker(s)

William Chong, MD

Panelist

William Chong, MD

  • Associate Director for Clinical Affairs, Office of Generic Drugs, CDER
  • FDA, United States
Lei Zhang, PhD

Panelist

Lei Zhang, PhD

  • Deputy Director, Office of Research & Standards, Office of Generic Drugs, CDER
  • FDA, United States
Lisa Bercu, JD

Panelist

Lisa Bercu, JD

  • Regulatory Counsel, Office of Generic Drug Policy
  • FDA, United States
Ashley Boam, MS

Panelist

Ashley Boam, MS

  • Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
  • FDA, United States
Susan Rosencrance, PhD

Panelist

Susan Rosencrance, PhD

  • Director, Office of Lifecycle Drug Products, OPQ, CDER
  • FDA, United States
Stelios Tsinontides, PhD, MA

Panelist

Stelios Tsinontides, PhD, MA

  • Office Director, OPMA, OPQ, CDER
  • FDA, United States