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

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

Facilitators

• 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