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 50^th Annual Meeting site and click on speakers-regulatory/government agency.

 

Contact: Tiffany Cohen
+1.202.499.4411
tcohen@reingold.com

 

###