2024 Combo Logo FDA

Back to agenda

2023 Combo Products Summit Workshop

session

Notified Body Opinion Workshop – Experiences And Lessons For Combination Products In EU

November 28, 2023 @ 8:00 am

-

10:30 am

Facilitators

(Leading Facilitator) Ryan McGowanDirector, Digital Devices and Combination Products, AstraZeneca

(Leading Facilitator) James WabbyGlobal Head – Emerging Technologies, Combination Products, and Devices, Abbvie

Arabe Ahmed, Bsi Group

Timothy ChesworthSenior Director Regulatory Affairs – Devices & Digital Therapeutic, AstraZeneca

Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie

Amanda MatthewsSenior Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer

It has been three years since Notified Body Opinions have been required for integral combination products in the European Union (EU) under the requirements of Article 117 of the EU Medical Device Regulations. In the intervening time, both industry and notified bodies have learned more about expectations of these submissions, however key elements also remain uncertain which places some combination products at approval risk due to lack of clarity on expectations. This session will provide an overview of Notified Body Opinions in EU, cover practical considerations and best practices in delivering the submissions, and explore some key areas of uncertainty such as post-approval substantial changes.

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