KEYNOTE LECTURE - Regulatory presentation: overview of the ICH M15 (MIDD) guideline
Kristin Karlsson (1), Flora Musuamba (2) and Efthymios Manolis (3)
(1) Affiliation1 Medical Products Agency, Uppsala, Sweden, (2) Federal Agency for Medicines and Health Products, Brussels, Belgium. University of Namur, Belgium, (3) European Medicines Agency, Amsterdam, Netherlands.
Objectives: To introduce the key content of the ICH M15 Guideline, in particular the newly introduced approach for assessment of MIDD evidence.
Overview/Description of presentation: The ICH M15 (MIDD) guideline is aimed to provide general recommendations for planning, model evaluation, and documentation of evidence derived from Model-Informed Drug Development (MIDD), defined as “MIDD evidence.” Accordingly, the guideline introduces a framework for assessment of MIDD evidence to inform decision-making and its use across the sequence of “planning and regulatory interaction” through to “implementation, reporting, and submission”. The presentation will shortly summarize the key elements of this new framework for assessment of MIDD evidence.
Video link:
https://www.youtube.com/watch?v=zW_WcXBpNbc