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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 6: Enforcement Insights to Navigate Decision-Making

Session Chair(s)

Kimberly  Belsky, MS

Kimberly Belsky, MS

  • Executive Director, Regulatory Policy and Intelligence, Regulatory Affairs
  • Mallinckrodt Pharmaceuticals, 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

  • Executive Director, Regulatory Policy and Intelligence, Regulatory Affairs
  • Mallinckrodt Pharmaceuticals, United States
Francis  Nguyen, PharmD

OPDP Enforcement Insights-Select Learnings

Francis Nguyen, PharmD

  • Assistant Director, Regulatory Advertising & Promotion
  • Bayer Healthcare Pharmaceuticals, United States
Heather E Rennie, JD

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

Heather E Rennie, JD

  • Executive Director, Managing Counsel, US Commercial Legal
  • Merck Sharp & Dohme Corp., United States

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