On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Hogan Lovells to Host FDLI cGMP Conference: Top FDA/CDER Compliance Officials Will Speak on a Range of cGMP Issues
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.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017