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Combination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019
November 28 @ 10:50 am – 2:20 pm
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.
- 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