Combination-Products-CGMP

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Combination Products CGMP

Session Chair(s)

Steven B. Binion

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

Becton Dickinson, United States

FDA issued the Current Good Manufacturing Practice (CGMP) Requirements for combination products to promote clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for organizations to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products. In this session, FDA will outline the final rule, discussing the requirement and expectations. Much of the session will be designed to provide an opportunity for audience participants to interact directly with CDER, CDRH, CBER and OCP.

Speaker(s)

CGMP Final Rule

John Weiner, JD

FDA, United States

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

Industry Perspectives

Alex Wesolowski

Becton, Dickinson and Company, United States

Vice President, Corporate RA

Industry Perspectives

Jeanmarie Sales

Medtronic, Inc., United States

Distinguished Reg Affairs Advisor

CDER, CDRH and CBER Perspectives

Edward Patten, MS

FDA, United States

Associate Director for Manufacturing Science, CBER

CDER, CDRH and CBER Perspectives

Steven Hertz, MBA, MS

FDA, United States

Consumer Safety Officer, Office of Pharmaceutical Quality, CDER

CDER, CDRH and CBER Perspectives

M. Isabel Tejero del Rio, MD, PhD

FDA, United States

Quality Systems Working Group Lead, DMQ, OC, CDRH

CDER, CDRH and CBER Perspectives

Melissa Torres, MS

FDA, United States

Associate Director for International Affairs, CDRH

Panel Discussion

All Session Speakers, United States

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DIA Meeting on Combination Products