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Director of FDA’s Center for Drug Evaluation and Research to Introduce New Office of Pharmaceutical Quality at DIA Annual Meeting

WASHINGTON — Mar 11, 2014

Janet Woodcock will discuss reorganization to consolidate quality-related functions.

U.S. Food and Drug Administration’s (FDA) Janet Woodcock will lead a discussion of the mission and function of FDA’s new Office of Pharmaceutical Quality at the DIA 2014 50th Annual Meeting in San Diego, to be held June 15 to 19.

Woodcock is director of FDA’s Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs, including biological therapeutics and generics. The recently established Office of Pharmaceutical Quality is tasked with enforcing existing quality standards throughout the lifecycle of a drug. CDER proposed a reorganization of quality-related functions into a single office; FDA announced the creation of OPQ in late February.

“We are thrilled to have Dr. Woodcock leading the discussion of the office’s important work and risk-based decision making in regulatory approaches,” said DIA Global Chief Executive Barbara L. Kunz. “FDA’s role in continual quality surveillance is essential to drug safety and of central interest to our attendees, stakeholders and the public.”

The session, “Introducing CDER’s Office of Pharmaceutical Quality,” is slated for June 17 from 1:30 p.m. to 3:30 p.m. The discussion will focus on the Office of Pharmaceutical Quality’s strategies for risk-based resource management and decision-making, maximizing the development and use of staff expertise, taking a proactive view of product quality through quality surveillance and enhancing the integration of review and inspectional functions.

Woodcock is one of dozens of FDA representatives invited to speak at the Annual Meeting. For information on related sessions, visit the DIA 50th Annual Meeting site and click on speakers-regulatory/government agency.

 

Contact: Tiffany Cohen
+1.202.499.4411
tcohen@reingold.com


 

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.
 
ABOUT DIA’s 2014 50th ANNUAL MEETING: Celebrate the Past – Invent the Future is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development and life cycle management of medical products. The meeting aims to foster innovation that will lead to the development of safe and effective medical products and therapies for patients. For more information, visit www.diahome.org/dia2014.