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Michael Kopcha

Director, (Super) Office of Pharmaceutical Quality "The views and information presented here are mine."

Michael Kopcha, Ph.D., R.Ph., serves as the Director of the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration.1 He took on this role in September 2015, succeeding Janet Woodcock who had been serving as the acting director.2

Dr. Kopcha is a highly motivated global executive with extensive experience in the pharmaceutical, generic, consumer health, device, and government regulatory sectors.4 Before joining the FDA, he worked as a vice president and global research and development franchise head for cough, cold, and respiratory products.6

In his current position, Dr. Kopcha oversees OPQ, which combines non-enforcement-related drug quality work into one super-office.1 The office is responsible for ensuring the consistent production of high-quality medicines, both brand-name and generic drugs. OPQ aims to provide a more coordinated and effective process for drug quality oversight, including establishing a more predictable and timely application approval process.2

Dr. Kopcha's LinkedIn username is michaelkopcha, where he describes himself as the "Director, (Super) Office of Pharmaceutical Quality".47 He uses this platform to share updates and information related to pharmaceutical quality and FDA initiatives.357

Highlights

Feb 12 · fda.gov
CDER Leadership Bios | FDA
May 12 · youtube.com
Pharmaceutical Quality Update by Dr. Michael Kopcha ... - YouTube
Pharmaceutical Quality Update by Dr. Michael Kopcha ... - YouTube

Related Questions

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Michael Kopcha
Michael Kopcha, photo 1
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Location

Silver Spring, Maryland, United States