Loading Events

« All Events

  • This event has passed.

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

11-28-2023 @ 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.

Leading Facilitators

  • 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
1300 Houston Street
Fort Worth, Texas 76102 United States