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Virtual Event

18 may 2020 10:00 a.m. - 20 may 2020 3:15 p.m.

(US Eastern Standard Time)

Fort Washington, PA 19034

Advertising and Promotion Regulatory Affairs Conference

Session 6: Enforcement Insights to Navigate Decision-Making

Session Chair(s)

Kimberly  Belsky, MS

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

Speaker

Kimberly Belsky, MS

Independent, United States

Reg Policy & Intell and AdPromo, Regulatory Affairs

Francis  Nguyen, PharmD

OPDP Enforcement Insights-Select Learnings

Francis Nguyen, PharmD

Bayer Healthcare Pharmaceuticals, United States

Assistant Director, Regulatory Advertising & Promotion

Heather E Rennie, JD

Is Private Enforcement the Answer: Lanham Act and Other Private Actions

Heather E Rennie, JD

Merck Sharp & Dohme Corp., United States

Executive Director, Managing Counsel, US Commercial Legal

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