Overview
Is my product a combination product? Which FDA Center will review my product? How will it be regulated? Sometimes the answers are not obvious. This webinar will begin with addressing these questions. Speakers will then delve into such topics as practices for preparing a Request for Designation (RFD) or Pre-RFD, pre- and post-market requirements for combination products, and other practical and legal considerations. The webinar will also include industry case studies on company hurdles and lessons learned when submitting a product.
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Speakers
John (Barr) Weiner, Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products
Scott Danzis, Partner, Covington & Burling LLP
Kirsten Paulson, Senior Director, Global Reg- CMC Medical Devices, Pfizer, Inc.
JOHN (BARR) WEINER is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a BA from Princeton University and a JD with honors from the Columbia University School of Law.
KIRSTEN PAULSON, RAC, is the Senior Director, Global Regulatory CMC-Medical Devices at Pfizer Inc., with the lead for Combination Products, diagnostics and software medical devices. She was previously the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD Medical Device and Diagnostics group. She began her career as an FDA medical device reviewer. Kirsten has a BS from Boston University and an MS in Bioengineering from Penn State.Virtual Learning FAQ
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