Woodcock WebEx on FDA's Office of Pharmacutical Quality

  • by: |
  • 05/12/2015

Understanding CDER’s “Super” Office of Pharmaceutical Quality and Its Effect on You
A One-On-One With FDA’s Dr. Janet Woodcock and Dr. Lawrence Yu

Wednesday, July 8, 2015  • 1:30 p.m. - 3:00 p.m. EDT

Sign up now for this exclusive question-and-answer webinar with FDA veteran Peter Pitts, President and Co-founder of the Center for Medicine in the Public Interest, as he speaks with Dr. Janet Woodcock, Director of CDER and the driving force behind the formation of the OPQ and Dr. Lawrence Yu, Acting Director of CDER’s Office of Pharmaceutical Science, to help you understand all the changes that will effect you.

They will discuss:

  • Why this new super office was formed and what offices goals are
  • How the formation will impact any pending business with the original eight offices
  • Whether or not you’ll need to set up new contacts with regard to review or quality issues
  • Are any changes coming to individual offices’ staffing or management?
  • The latest on the search for a permanent director to lead the new office

Plus, we set aside 30 minutes to give you the opportunity to have your own questions answered.

This webinar is of particular importance to anyone who has had dealings with any of the following offices, which the OPQ now incorporates:

  • Office of Program and Regulatory Operations (OPRO)
  • Office of Policy for Pharmaceutical Quality (OPPQ)
  • Office of Biotechnology Products (OBP)
  • Office of New Drug Products (ONDP)
  • Office of Lifecycle Drug Products (OLDP)
  • Office of Testing and Research (OTR)
  • Office of Process and Facilities (OPF)
  • Office of Surveillance (OS)


Your Expert Presenters

Janet Woodcock, M.D., is director of the Center for Drug Evaluation and Research (CDER) and also serves as acting director of CDER’s Office of Pharmaceutical Quality (OPQ). A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award, the American Medical Association's Nathan Davis Award, and Special Citations from FDA Commissioners. She joined FDA in 1986.

Dr. Lawrence X. Yu joined FDA in 1999 as a team leader in CDER’s Office of Pharmaceutical Science’s (OPS) Division of Product Quality Research, and was later promoted to deputy director in the Office of Generic Drugs. He currently serves as Acting Director, OPS, adjunct Professor of Pharmaceutical Engineering at the University of Michigan, and Associate Editor of AAPS J.

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. From 2002-2004 Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management.

Webinar Details

When?  Wednesday, July 8, 2015

Time? 1:30 p.m. – 3:00 p.m. EDT

There’s just one low registration fee per site regardless of how many participate. Generous multi-site discounts are available, too. Simply call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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