Bayesian methods are increasingly being considered to support dose optimization, extrapolation, and adaptive designs in clinical development. However, regulatory expectations vary across regions and continue to evolve.
This webinar brings together three regional perspectives on the current regulatory landscape: the FDA’s draft guidance on Bayesian statistics, China’s CDE guidance on Bayesian approaches, and Bayesian-relevant expectations embedded across EMA guidance documents.
Our speakers will explore what regulators expect when Bayesian methods are used to support decision-making, helping attendees better understand opportunities, challenges, and considerations for global development programs and submissions.
What You’ll Learn
- Key requirements from FDA’s draft guidance on the use of Bayesian methodology in clinical trials
- Commonalities and differences between FDA, CDE, and EMA expectations
- CDE expectations for Bayesian approaches within the Chinese regulatory environment
- Practical considerations for planning global regulatory strategies involving Bayesian methods
Where Bayesian-relevant expectations appear across EMA guidance documents *
Speakers:
- Christina Geyer, Consultant Statistician
- Maxwell Wang, Ph.D., Senior Statistician
- Johannes Schumacher, Ph.D., Principal Statistician
- Moderator: Billy Amzal, Ph.D.
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