Implications of Recent CIAs in the Pharmaceutical Industry: The Intersection of FDA Regulatory Oversight and Compliance
17 March 2011
12:00–1:30 pm EDT
The pharmaceutical industry is under increasing scrutiny arising from alleged misconduct in its development and commercialization activities. Government investigations alleging violations of the False Claims Act for failure to comply with provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), particularly relating to off-label promotion of drug products, have resulted in record fines and imposition of restrictive Corporate Integrity Agreements (CIAs).
This environment places greater emphasis on the regulatory function within companies to provide expertise and oversight to all aspects of the drug development and marketing process. This RAPS Webcast will review and analyze the regulatory issues addressed in recent CIAs, provide an understanding of how regulatory practice will play a critical role in identifying potential regulatory violations and identify processes to minimize compliance-related risks targeted by regulators.
Learning Level(s): Basic, Intermediate
Learning Objectives
Upon completion of this webcast, participants should be able to:
- Identify regulatory violations that were the subjects of the recent CIAs
- Recognize CIA provisions and their impact on company regulatory practice
- Explain OGD’s approval requirements for complex drug products; establishing “sameness” and therapeutic equivalence with the reference listed drug
- Counsel internal company functions on appropriate regulatory processes to mitigate compliance-related risks
Speakers
Howard L. Dorfman, counsel, Ropes & Gray LLP
Brian K. French, partner, Nixon Peabody LLP
Cost
Live Webcast Only: Members: $295 USD; Nonmembers: $369 USD
Webcast On-demand Recording Only: Members: $295 USD; Nonmembers: $369 USD
Live Webcast/On-demand Bundle: Members: $395 USD; Nonmembers: $469 USD
Cost is per site - unlimited participants!