Alston & Bird hosted this conference sponsored by the Food and Drug Law Institute (FDLI) in the firm's Washington, D.C. offices on July 10, 2013. Speakers at the conference included senior government officials from FDA and DOJ:
- Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA
- Laura A. Rich, Chief, Regulations and Policy Staff, Office of the Center Director, Center for Biologics Evaluation and Research, Office of Medical Products and Tobacco, FDA
- Douglas Stern, Deputy Director, Policy and Analysis, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA
- Jeffrey Steger, Assistant Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice
- Ilisa Bernstein, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, FDA
Alston & Bird Partner Cathy Burgess was a featured speaker during the program. Cathy moderated the session "Failure to Comply: What Are the Consequences?"
Professionals working in the pharmaceutical and biologics industries, especially lawyers, need to understand the current framework for creating and following current Good Manufacturing Practices (cGMPs), and the steep legal and regulatory consequences for failing to meet those standards. This one-day program was specifically tailored for lawyers, but appropriate for all drug and biologics stakeholders. The conference provided an overview of cGMPs (including revisions mandated by enactment of Section 711 of FDASIA), how FDA evaluates company compliance with cGMPs (including an examination of recent guidelines published by the International Conference on Harmonization and the latest developments on quality by design), and practical advice for how to remain current and compliant.
July 10, 2013
Alston & Bird LLP/The Atlantic Building/950 F Street NW/Washington, D.C.