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Bethesda North Marriott Hotel and Conference Center

2018年3月08日 (木) 午前 7:00 - 2018年3月09日 (金) 午後 3:00

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 6: Legal Update

Session Chair(s)

Coleen  Klasmeier, JD

Coleen Klasmeier, JD

Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice

Sidley Austin, LLP, United States

Advertising and promotion issues continue to arise in a wide range of legal contexts, from civil litigation brought by injured plaintiffs to state and local authorities acting under general consumer protection statutes and nuisance principles and a variety of civil and criminal investigations and settlement agreements arising under the False Claims Act. At the same time, the Food and Drug Administration’s implementation of the advertising and promotion provisions of the Federal Food, Drug, and Cosmetic Act has continued to develop in response to First Amendment pressures and other shifts in the external environment. This session will identify and summarize key developments in the law affecting manufacturer communications, with a focus on characterizing the enforcement and litigation risks confronting regulated entities. Our focus will include practical risk mitigation techniques and effective tools to remain up-to-date as the legal landscape continues to shift in this important area of manufacturer activity.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify the key Supreme Court cases from the past five years influencing FDA’s interpretation of its ad promo authorities under the FD&C
  • Characterize the principal shifts in FDA policy and enforcement reflecting the evolving legal landscape
  • Articulate at a high-level the most significant types of legal risk that can arise out of manufacturer communication activities

Speaker(s)

Coleen  Klasmeier, JD

Key Developments and FDA Implications

Coleen Klasmeier, JD

Sidley Austin, LLP, United States

Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice

Michael J Hulka

Civil Litigation Developments

Michael J Hulka

Eli Lilly and Company , United States

Senior Director, Assistant General Counsel

Margaret  Sparks

Criminal Enforcement and State AG Activity

Margaret Sparks

Sanofi US, United States

Associate Vice President

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