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Hyatt Regency Bethesda

Sep 28, 2015 7:30 AM - Sep 29, 2015 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development

Engage with key regulators and partners in practical approaches to navigate regulatory requirements, enhance collaboration and accelerate combination product development.

Session 8: Ask the Regulators

Session Chair(s)

Steven B. Binion

Steven B. Binion

Director, Policy, Technology, and Communication - Corporate Regulatory Affairs

Becton Dickinson, United States

Join this final session of the conference for a unique chance to meet with senior FDA leaders and ask questions regarding current issues and opportunities in the regulation of combination products in an open and interactive session.

Speaker(s)

Elizabeth  Baker

Panelists

Elizabeth Baker

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

Group Manager Licensing Division

Patricia  Love, MD, MBA

Patricia Love, MD, MBA

FDA, United States

Deputy Director, Office of Combination Products, OCPP, OC

William  H.  Maisel, MD, MPH

William H. Maisel, MD, MPH

FDA , United States

Deputy Director for Science and Chief Scientist, Director, ODE (Acting), CDRH

Diane  Maloney, JD

Diane Maloney, JD

FDA, United States

Associate Director for Policy, CBER

Thinh X. Nguyen

Thinh X. Nguyen

FDA, United States

Director, Office of Combination Products, OCPP

Douglas C. Throckmorton, MD

Douglas C. Throckmorton, MD

FDA, United States

Deputy Center Director for Regulatory Programs CDER

John  Weiner, JD

John Weiner, JD

FDA, United States

Associate Director for Policy, Office of Combination Products, OCPP, OC

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