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2023 Combo Products Summit Agenda

session

Workshop

November 28, 2023 @ 8:00 am

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5:10 pm

7:00 am – 8:00 am ————— Breakfast
8:00 am – 10:30 am ———— Notified Body Opinion Workshop – Experiences And Lessons For Combination Products In EU
10:00 am – 2:00 pm ———— FDA Office Hours
10:30 am – 10:50 am ———— Break
10:50 am – 2:20 pm ———— Combination Products Risk Management: Integration Of ICH Q9(R1) And ISO 14971:2019
11:50 am – 12:50 pm ———— Lunch
2:20 pm – 2:40 pm ————— Break
2:40 pm – 5:10 pm ————— Risk Management Application In Post-Market Safety & Other PMSR Hot Topics
5:10 pm – 5:30 pm ————— Q&A Session

For more details, check out session information by clicking this link!

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.

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© 2024 AFDO/RAPS Healthcare Products Collaborative