FDAnews Announces — Understanding CDER’s “Super” Office Of Pharmaceutical Quality and Its Effect on You Webinar, July 8, 2015

Share Article

Formation of the FDA’s “super” Office of Pharmaceutical Quality (OPQ) has been called one of the most important CDER developments in decades. In this exclusive question-and-answer webinar with FDA veteran Peter Pitts, President and Co-founder of the Center for Medicine in the Public Interest, 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 manufacturers understand all the changes that will effect them.

"Quality is an intrinsic part of a safe and effective medicine and the new super office is proof positive the FDA is working to enhance both pre and post-market vigilance." - Peter Pitts, President, Center for Medicine in the Public Interest

Formation of the FDA’s “super” Office of Pharmaceutical Quality (OPQ) has been called one of the most important CDER developments in decades. In this exclusive question-and-answer webinar with FDA veteran Peter Pitts, President and Co-founder of the Center for Medicine in the Public Interest, 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 manufacturers understand all the changes that will effect them.

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
**FDAnews Webinar**
July 8, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/cdersuperoffice

Formation of the FDA’s “super” Office of Pharmaceutical Quality (OPQ) has been called one of the most important CDER developments in decades. Are manufacturers prepared for the changes that come with consolidating eight previously separate offices into one? Drug, biotech or vaccine companies have questions. And FDAnews has answers — straight from the top.

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 manufacturers understand all the changes that will effect them.

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 manufacturers will 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 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)

Meet the 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.

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 and an Executive Partner at YourEncore. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute.

Who Will Benefit:

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

Conference Details:
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
**FDAnews Webinar**
July 8, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/cdersuperoffice

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/cdersuperoffice
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Share article on socal media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >