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Combination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019

November 28 @ 10:50 am 11:50 am

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.

Leading Facilitators

  • Tine Albeck, Senior QA – Global Quality Devices, ALK A/S


  • Milind Ganjawala, Center for Drug Evaluation and Research (CDER), FDA
  • Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC
  • Rick Wedge, Associate Research Fellow, Pfizer
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Fort Worth, Texas 76102 United States
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