PmcG_SGS-Brainstorming_1280x720-00_20190110-070159_1 We want to hear the voice of industry

Evening Discussion Group – Enhanced Approach for Analytical Procedures.

Feb 05, 2019 6:00 pm -9:00 pm, Radisson Suite Hotel Toronto Airport


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ICH has recently formed two new working groups: Q2 (R2)/Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation. These proposed guidelines are intended to complement ICH Q8 to Q12.
Q14 is proposed to harmonize the scientific approaches of Analytical Procedure Development, and to provide the principles relating to the description of the Analytical Procedure Development process. This new guideline is intended to improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.

We want to hear your thoughts and experiences and feed back comments/concerns to the new ICH working groups.