Oral: Keynote lecture

KEYNOTE LECTURE – Regulatory presentation: overview of the ICH M15 (MIDD) guideline

Thursday 16 October, 2025

Objectives: To introduce the key content of the ICH M15 Guideline, in particular the newly introduced approach for assessment of…

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KEYNOTE LECTURE – Industry presentation: practical application of the ICH M15 guideline approach for assessing MIDD Evidence

Thursday 16 October, 2025

Objectives: To illustrate the application of the ICH M15 guideline for assessing MIDD evidence Overview/Description of presentation: The ICH M15…

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