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Session 6: Enforcement Insights to Navigate Decision-Making
Session Chair(s)
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States
While the advertising and promotion regulations have not changed, areas of enforcement can evolve. Understanding current enforcement actions can help to navigate the complexities of risk-based decision-making. This session will provide insights and key learnings into recent FDA enforcement and potential impact beyond FDA (e.g., FTC, State AG’s, Lanham Act, private litigants).
Learning Objective : At the conclusion of this session, the participant should be able to:- Understand current enforcement trends and their impact
- Articulate impact beyond FDA enforcement
- Apply learnings and insights to decision making
Speaker(s)
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States
Speaker
Francis Nguyen, PHARMD
Assistant Director, Regulatory Advertising & Promotion, Bayer Healthcare Pharmaceuticals, United States
OPDP Enforcement Insights-Select Learnings
Heather E Rennie, JD
Executive Director, Managing Counsel, US Commercial Legal, Merck Sharp & Dohme Corp., United States
Is Private Enforcement the Answer: Lanham Act and Other Private Actions