The European Medicines Agency (EMA) formally qualified Certara’s Simcyp® Simulator, marking the first and only qualification of any physiologically-based pharmacokinetic (PBPK) platform to date. This milestone signals a major shift in how PBPK models are evaluated, trusted, and used in regulatory submissions.
Hear from the experts who paved the EMA PBPK review process about the significance of this qualification and insights from the HMA/EMA workshop on the regulatory assessment of mechanistic models.
In this webinar, you’ll learn:
- What the EMA’s qualification of the Simcyp Simulator means for developers, regulators, and broader model-informed drug development (MIDD) community
- Practical guidance on how sponsors can leverage the qualification to streamline regulatory submissions and reduce the need for clinical DDI studies
- Key takeaways from the HMA/EMA workshop on mechanistic model qualification
- Future areas of qualification including complex DDIs, transporters, specific populations
Whether you’re involved in modeling and simulation, regulatory strategy, or drug development, this session will provide valuable perspective on how to leverage mechanistic models in a rapidly advancing regulatory framework.
