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Revision of ICH Q2(R1) and the New Guidance

‐ Jul 13, 2021 11:45am

Efforts are underway to update and expand the applicability of ICH Q2(R1), Validation of Analytical Procedures, the authoritative guidance on analytical method validation. In parallel, the ICH Expert Working Group is drafting Q14, Analytical Procedure Development, to provide guidance on modern approaches in analytical method development and method lifecycle management. Q2(R1) and Q14 are intended to provide a roadmap for efficient communication between applicants and regulators on the approaches and expectations of advancing an analytical procedure from the definition of intended use through development, validation, and routine use through the lifecycle of the product. The session will include a brief overview of the workplans and current progress for the revision of Q2(R2) and the development of Q14, including regulator and industry perspectives on the value the new documents and case studies to demonstrate innovative approaches to analytical method development. A panel discussion will follow, providing an opportunity for audience engagement with the speakers and other experts. Finally, breakout sessions to allow for strategic dialogue and open exchange regarding specific topics relevant to these guidelines, such as expectations for robustness and use of Analytical Target Profiles.

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