OSD on ICH M10 Guidelines: Additional Considerations, Documentation and Reporting

When:  Oct 3, 2022 from 12:00 to 13:00 (ET)
Associated with  Bioanalytical Community

Please join the AAPS Bioanalytical Community on October 3rd @ 12:00 pm EDT for an Open Scientific Discussion:

ICH M10 Guidelines: Additional Considerations, Documentation, and Reporting

The sign-off of ICH M10 by regulators marks the culmination of a long effort to develop a global guidance for bioanalytical method validation.  While a global guidance will, in the long run, benefit the bioanalytical community, in the short term, labs will need to align their practices and procedures with the new guidance.  This OSD will review the sections of ICH M10 related to the additional considerations, documentation, and reporting sections of M10.  Differences between the global guidance and the current typical practices within the bioanalytical community will be reviewed and discussed.


Presenters: Steve Lowes (Q2 Solutions), Robert Dodge (Novartis)

Moderator: Sanjeev Bhardwaj (Janssen)


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Sanjeev Bhardwaj

[email protected]