VP of Scientific Consulting, BioIVT
BIOGRAPHY
OCT 10, 2023 8:00 AM PDT
Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance
Speaker
Event Date & Time
Date: October 10, 2023
Time: 8:00 AM (PDT), 11:00 AM (EDT), 5:00 PM (CEST)
Abstract
In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 with the goal of harmonizing member regulatory agencies’ guidelines to create a single guideline that will be used across all member countries. After a review period, the guideline will be adopted in early 2024.
Hear expert Dr. Brian Ogilvie discuss the differences between current in vitro drug-drug interaction guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan drug development strategies to meet the ICH M12 guideline.
Learning Objectives
- An understanding of the development impacts of the new ICH Drug Interaction Studies Guideline.
- Differences with current FDA, EMA and PMDA DDI guidance documents.
- How to plan drug development strategies to meet the ICH M12 guideline.
Webinars will be available for unlimited on-demand viewing after live event.
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