2026/05/12: EFSPI StatsLeaders Meeting Munich
- Mouna and Tobias lead a session on Engagement with Regulatory Agencies and Methodological Innovation.
2026/04/15: EFSPI Statistical Methodology Leaders F2F in Copenhagen
Topics that were discussed:
- Update from organizations.
- Change management tactics.
- Priority topics, see here.
2025/11/03: EMA workshop on external controls
- Mouna and Marc represented the group in the scientific committee while Natalia presented.
- Recording and slidedecks.
2025/09/10: EFSPI regulatory statistics workshop
- EFSPI method leaders (Mouna) presented the four priority topics.
- Tobias presented on credibility framework/assumptions.
- Nicky presented in the Bayes session.
- See here for recordings and slidedecks.
2025/05/13: EFSPI StatsLeaders Meeting in Copenhagen
- Mouna and Kaspar ran a session “Innovative clinical trial methodologies and their adoption - Priorities and Opportunities”.
2025/03/19: BBS webinar “From Statistical Innovations to Common Practice, How to innovate with impact?”
2024/11/13: Regular meeting of EFSPI / PSI regulatory eSIG with MHRA statisticians
EFSPI methods leaders also provided input into the agenda of this meeting, and some also attended. Below the protocol of the discussion.
2024/07/06: EMA multistakeholder workshop on general topics
EMA invited industry to propose topics for discussion, of which ten were selected for discussion, see the agenda below. Most short talks were given by members of the EFSPI statistical methodology leaders group.
2024/06/17: EMA multistakeholder workshop on Bayesian statistics
2024/05/06: EFSPI StatsLeaders Meeting at BMS in Boudry
- Mouna and Kaspar introduced the group.
Feedback
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