The Evolution of the M10 Guidance, the ICH Process, Adoption, & Implementation

When:  Jun 29, 2022 from 12:00 to 13:00 (ET)
Associated with  Bioanalytical Community

Please join the AAPS Bioanalytical Community on June 29th @ 12pm EDT for an Open Scientific Discussion:

The Evolution of the M10 Guidance, the ICH Process, Adoption, & Implementation

The ICH Harmonised Guideline for Bioanalytical Method Validation and Study Sample Analysis (M10), endorsed by the members of the ICH assembly on 24 May 2022, is now published on the ICH website ( Finalization of this globally harmonised bioanalytical guideline is a significant achievement and advancement.  Join us as experts in the field of Bioanalysis share the history of how this guideline came about, the process by which the working group progressed to a harmonised position, and what to expect now that ICH has published the guideline.  This OSD will be the first of a series planned for the community to interface and discuss ICH M10.


Moderator: Stephanie Cape (LabCorp Drug Development)

Presenters: Enaksha Wickremsinhe (Eli Lilly & Company) & Faye Vazvaei-Smith (Merck & Co. Inc.)


Interested in joining the Open Scientific Discussion committee or have an idea for an upcoming session? Please contact the OSD Committee Chair @ Sanjeev Bhardwaj


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Sanjeev Bhardwaj
(215) 628-7993
[email protected]