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FDA's Janet Woodcock, EMA's Emer Cooke Headline PDA Quality Metrics Conference

BETHESDA, Md., Nov. 17, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) today confirmed that seven officials from European and U.S. regulatory agencies will speak and at least seven more will participate in the upcoming 2014 PDA Pharmaceutical Quality Metrics Conference at the Omni Shoreham Hotel in Washington D.C., Dec. 2-4.

"PDA is pleased once again to have significant support from the regulatory agencies in the United States and Europe in our effort to help advance the use of metrics in the regulatory process," said PDA President Richard Johnson. "This year's interactive workshop will continue the discussion on FDA's utilization of robustness and compliance metrics as well as explore opportunities for measuring quality systems and culture, which began at the 2013 PDA workshop on metrics."

The opening plenary session of this year's conference features two talks by regulators. First, the U.S. FDA vision for surveillance of quality will be presented by Theresa Mullin, Ph.D., Director of Strategic Programs, CDER. The European regulatory perspective will follow, presented by Emer Cooke, Head of International Affairs, EMA.

The next plenary session provides a forum for regulators to expound the virtues of a strong quality culture. Gerald Heddell, Director of Inspection, Enforcement and Standards Division, MHRA, will elaborate on indicators for a quality culture. Russell Wesdyk, OPS Scientific Coordinator, CDER, will give the FDA's viewpoint. The fourth plenary session features Neil Stiber, Ph.D., Sr. Operations Research Analyst, CDER, who will outline FDA's new inspection protocol project.

FDA's Janet Woodcock, MD, Director, CDER, will set up the final panel discussion of the meeting with a discussion of the Agency's next steps regarding quality metrics and inspections. The panel will include Cooke, Heddell, Mullen, Stiber, Wesdyk, and Woodcock, as well as FDA's Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, OC.

Besides the regulatory speakers, plenary sessions include industry leaders representing companies like Johnson & Johnson, Amgen, Novartis and more.

Three breakout sessions will be held during the conference so participants can share ideas on the attributes of a quality culture, measuring the maturity of quality culture and systems and objective measures for quality culture. Each of these sessions will have discussion facilitators from the U.S. FDA and from industry.

FDA's Wesdyk and Stiber also served as co-chairs of the workshop planning committee.

About PDA – Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its almost 10,000 members worldwide. Go to to learn more.

Media Inquiries: Walt Morris, 301-656-5900, x. 148;

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