Advertising and Promotion Regulatory Affairs Conference

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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)

Trish Dring, JD, MS

Vice President, Associate General Counsel, Aurinia Pharmaceuticals Inc., United States

Speaker

Katherine Norris, MPA

Director, Life Sciences - Governance, Risk Management and Compliance, Guidehouse, United States