2025 Conference
CONFERENCE CO-CHAIRS
Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C.
Maarika Kimbrell
Partner
Morgan, Lewis & Bockius LLP
Former FDA Director, OND and CDER
Featured Speakers
Cathy L. Burgess
Partner, Leader of FDA, Food, Drug & Device Team
Alston & Bird
Jennifer D. Newberger
Director
Hyman, Phelps, & McNamara, P.C.
Thomas J. Cosgrove
Partner
Covington & Burling LLP
Bryant M. Godfrey
Partner
Foley Hoag LLP
Torrey Cope
Partner
Sidley Austin LLP
Joanne S. Hawana
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
HIGHLIGHTS
Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you:
- Navigating the Approval Process for Drugs and Biologics
- Clarifying the Clinical Trial Process for Drugs and Biologics
- Understanding the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
- Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
- cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process
- Advertising, Promotions, and Related First Amendment Concerns
- Understanding the Scope of FDA Enforcement Authority and Actions
Download 2025 Brochure
Flip through our conference brochure and discover the hot topics discussed.