Marching ICH Quality Guidelines Forward

New guidelines versus additional updates, flexibility versus detailed expectations, statistical tools versus application of knowledge, modeling versus specific data… what is your position? Proposals to revise ICH Q6B (Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) and ICH Q5C/Q1 (Quality of Biotechnology Products: Stability Testing of Biotechnological/Biological Products and related Q1 stability guidances) are currently on the table. Further guideline revisions and/or new guidelines will be added to the ICH agenda periodically. The timing of this conference presents an opportunity for strategic dialogue and open exchange regarding challenges and opportunities related to the current specification and stability guidelines prior to drafting of the revisions and an opportunity to reflect on additional challenges that could be addressed through novel ICH guidelines. This session will engage participants in discussions regarding next steps in the development of ICH Quality guidelines in support of harmonization, modernization, and use of scientific and regulatory best practices to advance the future of medicines globally.