Slides from the OSD presentation on June 29th are attached. Please reach out to me if you are unable to download.
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<u1:p></u1:p>
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 (https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf) 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. Please join us for this first OSD in a planned series for the community to interface and discuss ICH M10.
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Sanjeev Bhardwaj
Sr. Scientist
Janssen R&D
Springhouse PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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