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Session 12: Beyond the Letter-Recent and Relevant Legal Cases
Session Chair(s)
Carla Brooks, MSc, RAC
Senior Director, Regulatory Affairs, Advertising and Promotion
Blueprint Medicines Corporation, United States
There have been some interesting legal cases in the past year or so that are relevant to what we do—e.g., recent Park Doctrine, Lanham Act, and False Claims cases. Topics to include: Intended use proposed regulation, the recent Purdue, McKinsey and Humira Settlements and OIG Special Fraud Alert.
Learning Objective : At the conclusion of this session, participants should be able to:
- Determine the key aspects of recent cases
- Assess the impact of latest enforcement trends beyond FDA
- Discuss examples and apply insights to decision making
Speaker(s)
Speaker
Trish Dring, JD, MS
Aurinia Pharmaceuticals Inc., United States
Vice President, Associate General Counsel
Speaker
Katherine Norris, MPA
Guidehouse, United States
Director, Life Sciences - Governance, Risk Management and Compliance