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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 3: CGMP Guidance - Part Two - A Panel Discussion

Session Chair(s)

Steven B. Binion

Steven B. Binion

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

Becton Dickinson, United States

Session 3: CGMP Guidance - Part Two - A Panel Discussion

Speaker(s)

Steven  Hertz, MBA, MS

Panelists

Steven Hertz, MBA, MS

FDA, United States

Consumer Safety Officer, Office of Pharmaceutical Quality, CDER

Edward  Patten, MS

Edward Patten, MS

FDA, United States

Associate Director for Manufacturing Science, CBER

Melissa  Burns, MS

Melissa Burns, MS

FDA, United States

Senior Program Manager, Office of Combination Products, OCPP, OC

Francisco  Vicenty

Francisco Vicenty

FDA, United States

Supervisory Consumer Safety, CDRH

Rakhi  Dalal-Panguluri, PhD

Rakhi Dalal-Panguluri, PhD

FDA, United States

Toxicologist, CDRH

Melissa  Torres, MS

Melissa Torres, MS

FDA, United States

Associate Director for International Affairs, CDRH

James L. Dunnie

James L. Dunnie

FDA, United States

Consumer Safety Officer, Office of Regulatory Affairs

Paula  Katz, JD

Paula Katz, JD

FDA, United States

Director, Manufacturing Quality Guidence & Policy Staff, CDER

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