Clinical pharmacology is being reviewed differently.
With ICH M13A finalized, ICH M15 emerging, and increasing reliance on model-informed evidence, regulators are no longer asking whether studies were conducted, they are asking whether the totality of evidence is credible.
This executive-level on-demand webinar brings together former FDA, EMA, MHRA, and PMDA clinical pharmacology reviewers to share how regulatory expectations are shifting and where sponsors most often misjudge the line between confidence and concern.
This is not a guidance walkthrough.
It is a strategic conversation about how submissions are actually evaluated heading into 2026.
You will learn how regulators:
- Decide whether to trust model-informed evidence
- Evaluate PBPK, QT, and MIDD strategies under real review pressure profiling
- Interpret global harmonization versus local regulatory nuance
- Assess the CMC–Clinical Pharmacology interface
- Set expectations for clinical pharmacology submissions in 2026 and beyond
This webinar is ideal for:
- Heads, VPs, and Directors of Clinical Pharmacology
- Regulatory Affairs leaders (global or regional)
- Clinical Pharmacology, Pharmacometrics, and MIDD leads
- Clinical Development and Program Leaders (Phase I–III)
- Translational Medicine and Early Development leaders
- R&D and Development executives in biotech and pharma
Speakers:
- Eva Berglund, PhD
- Blaire Osborn, PhD
- Justin Hay, PhD
- Paola Coppola, MSc
- Mayumi Hasegawa, PhD
- Shalini Yapa
