Biozentrum Basel and hybrid online
December 10, 2026 – 14:00-18:00
Hybrid and F2F at Biozentrum Basel, Hörsaal U1.101
Registration and Costs: registration mandatory; attendance is free virtually and costs 60€ for F2F.
Organizers:
Michael Krams (Berry Consultants), Kaspar Rufibach (Merck KGaA), Lilla Di Scala (J&J), Marisa Bacchi (AlfaSigma).
Objective of the workshop:
The workshop asks three fundamental questions: WHY BAYES? What important drug-development problems can Bayesian thinking help solve? WHEN BAYES? When is the potential gain sufficiently relevant to justify additional assumptions and model influence? HOW DO WE TRUST IT? What evidence and evaluations are needed before Bayesian information can materially influence an important development or regulatory decision? The workshop provides expert and regulatory views in how to untangle these questions.
ICH M15 may provide a useful common language for answering them. Its concepts of context of use, model influence, consequence of a wrong decision, model risk, technical criteria and proportionate evaluation provide a framework through which the value and credibility of Bayesian approaches can be considered together.
Confirmed speakers: John Scott (FDA), Tobias Fellinger (AGES), Kristin Karlsson (Swedish Medical Products Agency, vice-chair EMA MWP, rapporteur of ICH M15 expert writing group),
Andy Grieve (UCB), Nicky Best (GSK), Scott Berry (Berry Consultants), Kaspar Rufibach (Merck KGaA) and Michael Krams (Berry Consultants).
For more details:
https://baselbiometrics.github.io/home/docs/upcoming/20261210/agenda.pdf
