| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Natalia Muehlemann & Alfredo Farjat | Cytel & Bayer | Strategies to overcome challenges of eligibility criteria for historical data as External Control Arm source | link |
Past events with contributions from the working group
Below a list of past events with contributions of the WG, with links to slidedecks and recordings (where available).
30.06.2026: Causal Inference SIG Webinar: Modern Approaches for Covariate Adjustment in Clinical Trials
Contribution of the working group: Co-organizers
19.05.2026: Regular meeting of EFSPI / PSI regulatory eSIG with MHRA statisticians
Contribution of the working group: Planning of agenda, input into discussion.
12.05.2026: EFSPI StatsLeaders F2F
Contribution of the working group: Mouna and Tobias lead a session on Engagement with Regulatory Agencies and Methodological Innovation.
Munich / Germany
15.04.2026: EFSPI Statistical Methodology Leaders F2F
Copenhagen / Denmark
03.11.2025: EMA workshop on external controls
Contribution of the working group: Member of Scientific Committee (Mouna & Marc), invited talk (Natalia).
Amsterdam / Netherlands
13.09.2025: BBS webinar “From Statistical Innovations to Common Practice, How to innovate with impact?”
10.09.2025: EFSPI regulatory statistics workshop
Contribution of the working group: Invited talks.
Basel / Switzerland
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Mouna Akacha & Kaspar Rufibach & Cornelia Ursula Kunz | Novartis & Merck KGaA & Boehringer Ingelheim | Strategic priorities in pharmaceutical statistics – A quantitative drug developer’s perspective | link |
| Nicky Best | GSK | Communicating the value of Bayesian approaches in clinical trials: is it just a prior issue? | link |
| Tobias Mielke | J&J | ICH-M15 to support credibility assessment for Bayesian modelling | link |
13.05.2025: EFSPI StatsLeaders F2F
Contribution of the working group: Organization of a session.
Copenhagen / Denmark
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Mouna Akacha & Kaspar Rufibach | Novartis & Merck KGaA | Innovative clinical trial methodologies and their adoption - Priorities and Opportunities | No presentation available |
13.11.2024: Regular meeting of EFSPI / PSI regulatory eSIG with MHRA statisticians
Contribution of the working group: Planning of agenda, input into discussion.
06.07.2024: EMA multistakeholder workshop on general topics
Contribution of the working group: Invited talk
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Henrik Ravn | Novo Nordisk | Covariate adjustment in randomised clinical trials | No presentation available |
| Tobias Mielke | J&J | Multiplicity adjustments in multi-armed trials with inferentially independent hypotheses | No presentation available |
| Christian Piepper & David Wright | Novo Nordisk & AstraZeneca | Meta-analyses and the estimand framework | No presentation available |
| Marc Vandemeulebroecke | UCB | Augmented controls in the confirmatory setting | No presentation available |
| David Wright | AstraZeneca | Extrapolation across related diseases | No presentation available |
17.06.2024: EMA multistakeholder workshop on Bayesian statistics
Contribution of the working group: Invited talk
Amsterdam / Netherlands
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Nicky Best | GSK | Benefits and challenges of using Bayesian methods to support regulatory decision-making | No presentation available |
| Natalia Mühlemann & Jan Priel | Cytel | Bayesian methods without borrowing in ultrarare diseases | No presentation available |
| Tobias Mielke | J&J | Application of ICH-M15 for Bayesian Modelling - Using a systematic model assessment framework to support design submission and discussion | No presentation available |
06.05.2024: EFSPI StatsLeaders F2F
Contribution of the working group: Invited talk
Boudry / Switzerland
| Speaker | Institution | Title | Download slides |
|---|---|---|---|
| Mouna Akacha & Kaspar Rufibach | Novartis & Roche | Introduction to the new EFSPI statistical methodology leaders group | No presentation available |