This webinar explores the evolving regulatory landscape for Model-Informed Drug Development (MIDD), focusing on the impact of the recent draft ICH M15 guidance. Certara’s global experts discuss the increasing role of MIDD across the drug development lifecycle, highlight key regulatory considerations in the application of MIDD, and provide insights on how to best leverage and implement the framework presented by the draft ICH M15 guidance within drug development programs.
Key takeaways
- MIDD as a Continuum
- Regulatory Acceptance of MIDD Solutions
- Understanding the ICH M15 Guidance on MIDD
- Preparing for Guidance Implementation – Future of MIDD Impact
講演者
- Hannah Jones – SVP, PBPK Consultancy Services
- Rik de Greef – SVP, Quantitative Science Services
- Krithika Shetty – Sr. Director, Clinical Pharmacology
- Eva Gil Berglund – Sr. Director, Regulatory Strategy
