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Kopcha Named Director of FDA Quality Office


October 02, 2015.

Industry veteran Michael Kopcha, a pharma was named the permanent director of FDA’s Office of Pharmaceutical Quality (OPQ) last week. He will join the Center for Drug Evaluation and Research (CDER) in November pending ethics clearance.

FDA’s OPQ was launched in January 2015 to implement processes and policies to provide better alignment among review, inspection, and research functions.

Kopcha will lead OPQ in planning and implementing strategies to drive pharmaceutical quality, with a goal of providing for an efficient pharmaceutical manufacturing sector that reliably produces high-quality medicines without extensive regulatory oversight, an FDA press release reported.

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