In June 2022, the ICH released the first draft of its harmonized 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 agenciesâ€™ guidelines to create a single guideline that will be used across all member countries.
Join us to hear drug-drug interaction (DDI) experts, Drs. Brian Ogilvie and Maciej Czerwinski, discuss the differences between current in vitro DDI guidance from the relevant US FDA, EMA and PMDA guidance documents, and how to plan drug development strategies to meet the ICH M12 guideline.
Key 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.
Who Should Attend:
- Research scientists and drug development leadership aiming for successful IND / NDA submission, needing to meet regulatory requests and expectations, desiring to formulate a development plan that mitigates risks of late stage failure, or simply wanting to better understand the ADME properties and potential DDI risks of their compound.