European Statistical Forum

In 2020 the revision of ICHE9 has became effective in the ICH regions.
Beyond the immediate operational consequences in terms of study documentation development, it has become clearer and clearer that the introduction of the Estimand framework may require methodological solutions which were not common practice in drug development when the revised guidance was released.

In this context, causal inference, or the problem of causality in general, has received a lot of attention in recent years. It appears to provide a suitable methodological framework for tackling some of these challenges.

Five years from now the event touched on Estimands. In this year's edition, the ESF goes back to Estimands to better understand the implications of the introduction of the ICHE9 (R1) guidance in terms of how the traditional approach of statistical inference may be affected in its fundamentals of sample size, testing, and estimation by the arrival of causal inference.

The conference will focus, among others, on the following areas:

• Regulatory perspective on study design development based on causal inference methods
• Operational implementation of causal inference methods
• Novel approaches based on causal inference methodologies
• Real case studies and practical approaches

Scientific Board
Jens-Otto Andreas - Project Lead Statistician at UCB Biosciences GmbH
Lisa Comarella - Director Biostatistics at CROS NT
Giacomo Mordenti - Head of Biostatistics & Data Management Europe at Daiichi Sankyo Europe GmbH
Marc Vandemeulebroecke - Global Group Head for Dermatology at Novartis Biostatistics

Who should attend?
The conference is addressed to statisticians, pharmacometricians, physicians, regulators, academia and other experts interested in the field belonging to: Pharmaceutical, and Biotechnology companies, CROs, Universities/Hospitals, Academic Research.