Webinar Overview
The recently released update to the International Council of Harmonisation (ICH) M12 guidelines provides a definitive version of their guidance for Drug-Drug Interaction (DDI) studies. These new, final guidelines are intended to replace regional and local guidelines to become the global standard for addressing DDI. The document offers updated recommendations for your in vitro and clinical study design and data interpretation.
In this webinar, we focus on how the ICH M12 effects your in vitro studies, and cover:
- Key changes that have been made in 2024’s final updates
- The main differences compared to the 2020 FDA DDI guidelines
- Major suggestions that were adopted from the 2022 public consultation of the previous draft
- How the guidelines approach new modalities
- The recommended timing for generating the required in vitro DDI data
The presentation includes a panel discussion with the presenters to address first impressions, and to discuss application considerations and future perspectives.
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Webinar Presenter
Noémi Szili, PhD
Product Manager, DMPK
Charles River
Webinar Panelists
Michael Shockley
Principal Scientist, In Vitro
Charles River
Manu Kohli, PhD
Principal Scientific Advisor
Charles River