The Most Important Legal Cases Regulatory Affairs Specialists Absolutely Must Understand
Legal developments directly impact the jobs and daily responsibilities of regulatory affairs specialists.
Legal expert William Janssen — Professor of Law, Charleston Law School — on providea a practical explaination of recent key decisions that affect what regulatory affairs does every day, in ways you may not have realized before.
The cases covered include:
First Amendment and Off-Label Promotion
Amarin v. United States (S.D.N.Y. 2015)
Caronia v. United States (2d Cir. 2012)
Sorrell v. IMS Health (U.S. 2011)
Promotion, FDA, and FTC
POM Wonderful LLC v. FTC (D.C. Cir. 2015)
Prosecuting Executives
United States v. Quality Egg, LLC (N.D. Iowa 2015)
Bold Frontiers in Federal Preemption
Caplinger v. Medtronic, Inc. (10th Cir. 2015)
In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal. 2015)
Impossibility Preemption & Drug Design
Yates v. Ortho-McNeil-Janssen Pharma (6th Cir. 2015)
After listening to this session you’ll be able to:
Develop regulatory plans and programs that are compliant with significant critical recent court rulings
Better understand how the legal process impacts regulatory affairs
Collaborate more effectively with your general counsel, in-house, and outside counsel in developing and implementing regulatory strategy
Discuss with authority the most important recent cases impacting your company from a regulatory perspective
Order today and learn from a legal expert how to develop regulatory strategies to enable you to comply with court decisions and existing rules and guidelines.
Compliance officers
General/corporate counsel
Executive management
Quality assurance
Risk management specialists
Outside attorneys
Regulatory/legislative affairs professionals
Department supervisors/directors
William Janssen, Professor of Law, Charleston School of Law
William M. Janssen joined the Charleston School of Law faculty in 2006 after a lengthy practice with the mid-Atlantic law firm of Saul Ewing LLP, where he was a litigation partner, a member of the firm’s seven-person governing executive committee, and chair of the interdisciplinary Life Sciences Practice Group. He concentrated his practice in pharmaceutical, medical device, and mass torts defense and risk containment.