Understanding CDER’s “Super” Office of Pharmaceutical Quality and Its Effect on You - Webinar CD/Transcript

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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

Order  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

This presentation 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)

This course will be of benefit:

  • Regulatory affairs professionals
  • Legal counsel
  • Compliance officers
  • Drug approval management
  • Pharmaceutical quality management personnel
  • C-suite executives

From the following companies:

  • Drug manufacturers
  • Biotech manufacturers
  • Combination products manufacturers
  • Consulting and legal organizations
  • Organizations involved in pharmaceutical quality
  • Wall Street and venture capital firms

Meet Your 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). OPQ combines non-enforcement-related drug quality work into one super-office, creating one quality voice and improving FDA’s oversight of quality throughout the lifecycle of a drug product. OPQ creates a uniform drug quality program across all sites of manufacture, whether domestic or foreign, and across all drug product areas – new drugs, generic drugs, and over-the-counter drugs. 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. Dr. Woodcock received her medical degree from Northwestern Medical School. She has held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. 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. Dr. Yu received a B.S. in Chemical Engineering from Zhejiang Institute of Technology, China; M.S. in Chemical Engineering from Zhejiang University, China; M.S. in Pharmaceutics, University of Cincinnati; and a Ph.D. in Pharmaceutics, University of Michigan. Before joining FDA, Dr. Yu worked at both Glaxo and Pfizer (Pharmacia & Upjohn).

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. He served on the agency’s obesity working group and counterfeit drug taskforce. He is the editor of the new book, Coincidence or Crisis, a discussion of global prescription medicine counterfeiting. He has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University.