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.

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.

Register

Webinar

$99
  • +$100 for non-members

Webinar & Recording

$149
  • +$100 for non-members

Student

$29
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Those registering on the day of the webinar will receive an access link via email upon successful payment.

We use Zoom to conduct webinars which works on most devices. You may participate in the webinar on a mobile device via the Zoom App or by dialing in. If you require the dial in information, please contact Coleen Carney at [email protected].

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If multiple people at your organization wish to participate from separate devices, each will be required to purchase access.