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.