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Bethesda North Marriott Hotel and Conference Center

Oct 25, 2017 7:00 AM - Oct 26, 2017 3:30 PM

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

Combination Products Conference

Innovation and New Frontiers

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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

Global regulatory requirements for combination products continue to evolve. This session will provide insight into how to navigate the disparate requirements, and a look to future developments in this space, including opportunities for greater harmonization and convergence.

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

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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