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2023 Combo Products Summit Workshop

session

Combination Products Risk Management: Integration Of ICH Q9(R1) And ISO 14971:2019

November 28, 2023 @ 10:50 am

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2:20 pm

Facilitator

(Lead Facilitator)Tine Albeck, Senior Quality Assurance Professional, ALK A/S

Milind Ganjawala, Division Director of Drug Quality II, Center for Drug Evaluation and Research (CDER), FDA

Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC

Rick Wedge, Compliance Lead / Associate Research Fellow, Pfizer

THIS TOPIC WILL BE SPLIT INTO TWO PARTS, WITH A BREAK IN THE MIDDLE FOR LUNCH. VIEW MORE ABOUT THE TOPIC BELOW:

ICH Q9(R1) has recently been adopted (January 2023), and ISO 14971:2019 has been recognized as a global harmonized standard. Combination Products Risk Management leverages and integrates each of these. Review and discuss the latest on each of the harmonized standards and discuss expectations for/ challenges with integration for combination products.

Download Activity Documents

 

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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