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Bethesda North Marriott Hotel and Conference Center

2017年10月25日 (水) 午前 7:00 - 2017年10月26日 (木) 午後 3:30

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

Combination Products Conference

Innovation and New Frontiers

Session 6: Navigating Global Combination Product Regulations

Session Chair(s)

Carla  Cartwright, JD, LLM

Carla Cartwright, JD, LLM

Director, Federal Affairs

Johnson & Johnson, United States

Kim  Quaintance-Lunn

Kim Quaintance-Lunn

Vice President, Regulatory Affairs Americas

Bayer AG, United States

Learning Objective :
  • Discuss the challenges associated with global registration of combination products
  • Describe regulatory strategies for navigating differing requirements in different countries
  • Explain efforts that are underway to address differences across regions/HTAs
  • Speaker(s)

    Demetra  Macheras, MBA

    Regulatory Policy for Combination Products: A Global View

    Demetra Macheras, MBA

    AbbVie, United States

    Director, Regulatory Policy and Intelligence - Regulatory Affairs

    Nicole  Smith

    Panelist

    Nicole Smith

    Johnson & Johnson, United States

    Senior Director, Global Regulatory Affairs Policy & Intelligence Medical Devices

    Elizabeth  Baker

    Changes Ahead for Combination Products in Europe

    Elizabeth Baker

    Medicines and Healthcare Products Regulatory Agency (MRHA), United Kingdom

    Group Manager Licensing Division

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