2024 Combo Logo FDA

Back to agenda

2023 Combo Products Summit Agenda

session

Platform Drug-Delivery Devices: Regulatory And Technical Considerations

November 29, 2023 @ 11:00 am

-

12:25 pm

Moderator

Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech

Speaker

James Bertram, Director of the Office of Combination Products (OCP), FDA

Jiaying Shen, Distinguished Scientist, Merck

Kent Abrahamson, Director, Combination Product and Device Development, Abbvie

Patricia Love, Deputy Director, FDA’s Office of Combination Products (OCP), FDA (Invited)

Regulatory and technical perspectives for the following topics will be explored during this session: (a) definition of platform for drug-delivery devices, (b) set realistic expectation of “Device Platform” Approach, (c) approaches to develop these platforms, and (d) approaches to apply platform data (molecule-agnostic) and the need to create molecule-specific data. Join in the discussion and help us find a common understanding of what a “platform” means and the implications!

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

Newsletter

Stay in the know about upcoming events and breaking news from the collaborative.

Subscribe

ContACT

Have questions about our events or how to get involved with one of our committees or workgroups?

Get in touch

© 2024 AFDO/RAPS Healthcare Products Collaborative