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Bethesda North Marriott Hotel and Conference Center

Feb 28, 2019 7:00 AM - Mar 01, 2019 3:00 PM

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

Advertising and Promotion Regulatory Affairs Conference

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Session 11: Sessions Track B: Pre-Approval Activities: How Much Information is Too Much?

Session Chair(s)

Kimberly Belsky, MS

Kimberly Belsky, MS

Reg Policy & Intell and AdPromo, Regulatory Affairs

Independent, United States

Pre-approval activities as well as disease awareness are the cornerstone of market readiness. Innovative, complex medicines and novel mechanisms of actions are leading the healthcare environment. This session will provide essential regulatory and legal strategic thinking regarding messaging to avoid unintended noncompliance when planning and executing pre-approval activities.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss the basic regulatory requirements regarding pre-approval activities and past enforcement actions
  • Leverage pre-launch strategic and tactical actions that reflect today’s regulatory environment including Payer discussions
  • Integrate legal and compliance opportunities and risk mitigation into pre-approval actions

    Speaker(s)

    Kevin Stark, MBA, RAC

    Speaker

    Kevin Stark, MBA, RAC

    Mallinckrodt, United States

    Executive Director, Regulatory Affairs

    Joanne Curley, MBA

    Speaker

    Joanne Curley, MBA

    Jazz Pharmaceuticals, Inc., United States

    Vice President, Head of Global Regulatory Affairs

    Kellie B. Combs, JD

    Speaker

    Kellie B. Combs, JD

    Ropes & Gray LLP, United States

    Partner

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