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Focus on Regulation

Hogan Lovells to Host FDLI cGMP Conference: Top FDA/CDER Compliance Officials Will Speak on a Range of cGMP Issues

The Food and Drug Law Institute (FDLI) will hold its “Understanding cGMPs—What Attorneys Need to Know” conference at the Washington, DC office of Hogan Lovells on July 15, 2014. You can register for the conference here. A copy of the conference agenda is available here.

During the conference, which is specifically tailored for lawyers but appropriate for all drugs and biologics stakeholders, attendees will hear from top FDA/CDER Compliance officials, in-house counsel, Hogan Lovells’ lawyers, and others, on how FDA evaluates company compliance with current good manufacturing practice (cGMP) and responds to noncompliance. The conference will highlight recent cGMP developments and provide updates on FDA authority. It will also expand beyond the United States to consider global issues such as import/exports and international inspections.

Here’s a list of confirmed FDA Speakers:

Ilisa B.G. Bernstein, Pharm.D., Deputy Director, Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco (OMPT)

Thomas Cosgrove, Acting Director, Office of Manufacturing and Product Quality, OC, CDER, OMPT

Richard L. Friedman, Associate Director, OMPQ, OC, CDER, OMPT

Alicia Mozzachio, Branch Chief, OMPQ, OC, CDER, OMPT

Carmelo Rosa, Division Director, Division of International Drug Quality, OMPQ, OC,CDER, OMPT

Hogan Lovells’ Philip Katz will open the conference and discuss the importance of cGMP compliance in the current regulatory environment, and Hogan Lovells’ Jim Johnson will be presenting on a panel discussing “The Nuts & Bolts of cGMPs: Updates on FDA Authority,” which will focus on a range of practical cGMP considerations and recent developments.