Recordings

Recordings of those sessions where all presenters have given consent (Sessions 5 might be added later, pending speaker consent):

Number	Session		Link (if available)
1	Regulatory and HTA update		x
2	Synthetic and other baseline covariates: The promise of smaller and faster clinical trials through prognostic digital twins		x
3	Complex innovative trials for regulatory decision-making		x
4	How to get most out of Scientific Advice		x
5	Use of non-RCT studies in regulatory decision-making		x
6	Short Topics		x

Material

Opening

Talk	Speaker and affiliation	Talk title	Download (if available)
1	Justine Rochon (Boehringer Ingelheim, EFSPI president)	Opening remarks	x

Session 1: Regulatory and HTA update

Talk	Speaker and affiliation	Talk title	Download (if available)
1	Kristin Karlsson (Swedish Medical Products Agency, Uppsala University, EMA, Vice-chair MWP)	EMA Methodology Working Party update	x
2	Eftychia-Eirini Psarelli (University of Liverpool, EMA)	EMA update on submission of individual patient data from clinical trials	x
3	David McConnell (Statistician National Centre for Pharmacoeconomics, Ireland, Methodology Subgroup of HTA CG)	Update on joint HTA work under the EU HTA Regulation	x

Short topics

Talk	Speaker and affiliation	Talk title	Download (if available)
1	Fredrik Öhrn (Janssen)	Formal statistical requirements for a pivotal trial to support approval of a combination drug	x
2	Betty Molloy (Novartis)	Use of RWE in drug labelling	x
3	Patrick Schloemer (Bayer)	Hierarchical Composite Endpoints for Chronic Kidney Disease Trials	x
4	Simon Wandel (Novartis)	What’s the rule for the pool?	x
5	Sandro Gsteiger (Roche) and Anders Gorst-Rasmussen (Novo Nordisk on behalf of the PSI/EFSPI HTA Special Interest Group)	Surrogate endpoints - can EMA and EU HTA align on common standards?	x
6	Susan Robson (Roche)	Data Quality issues in IITs	x

Session 2: Synthetic and other baseline covariates: The promise of smaller and faster clinical trials through prognostic digital twins

Talk	Speaker and affiliation	Talk title	Download (if available)
1	Andreas Brandt (BfArM, EMA)	Covariate Adjustment: Traditional principles and challenges by new approaches	x
2	Courtney Schiffman (Genentech Roche)	Strategic considerations and value of covariate adjustment	x
3	Daniel Rubin (FDA)	Adjusting for covariates in randomized clinical trials for drugs and biological products	x

Session 3: Complex innovative trials for regulatory decision-making

Talk	Speaker and affiliation	Talk title	Download (if available)
1	Khadija Rantell (MHRA), Frank Bretz (Novartis), Hans Ulrich Burger (Roche)	Some guidance on when applying adaptive designs	x
2	Wolfgang Jacquet (Vrije Universiteit Brussel, EMA) and Benjamin Hofner (Paul-Ehrlich Institut, EMA)	Platform trials in a confirmatory regulatory setting – generating thoughts and directions	x
3	Dieter Haering (Novartis)	Experience with and learnings from regulatory interactions around innovative trial designs based on the NEOS study	x

Session 4: How to get most out of Scientific Advice

Talk	Speaker and affiliation	Talk title	Download (if available)
1	Tommi Nurminen (fimea, EMA) and Antero Kallio (fimea, EMA)	How to efficiently leverage scientific advice - a joint statistical and clinical perspective	x
2	Gergő Merész (Co-Chair of the JSC Subgroup (HTA R))	HTA Joint Scientific Consultation	x
3	David Wright (AstraZeneca)	Tips on a) what questions to ask regulators and HTAs, b) interpreting the answers given and c) what to do when different authorities give conflicting advice	x

Session 5: Use of non-RCT studies in regulatory decision-making

Talk	Speaker and affiliation	Talk title	Download (if available)
1	Kit Roes (Radboud Universiteit, EMA)	Single Arm Trials: The EMA Reflection Paper	x
2	Mark Levenson (FDA)	United States FDA Real World Evidence Program: A Quick Tour	x
3	Pallavi Mishra-Kalyani (FDA)	Regulatory Issues with the Use of External Controls and the US FDA RWE Program	x
4	Emmanuel Zuber (Novartis)	External control for approval and labeling: Two case studies trying to figure out when it is worth it	x
4	Stefan Lange (IQWiG)	HTA view on the EMA draft reflection paper and the FDA guidance	x

Posters

Talk	Speaker and affiliation	Talk title	Download (if available)
1	EFSPI / PSI & ASA biopharmaceutical section oncology estimand working group (conditional marginal taskforce)	Conditional and Unconditional treatment effects in randomized clinical trials: trials: EstimandsEstimands, Estimation, and Interpretation, Estimation, and Interpretation	x
2	EFSPI / PSI Regulatory SIG	Regulatory ESIG	x
3	EFPIA / EFSPI estimand implementation working group	How the “Estimand Implementation Working Group” brings together statisticians and clinicians to support the estimand journeystatisticians and clinicians to support the estimand journey	x
4	EFSPI / PSI biomarker SIG	The Biomarkers European Special Interest Group: European Special Interest Group: Where are we now?Where are we now?	x
5	EFSPI / PSI historical data SIG	Beyond the classical type I error: Bayesian metrics for Bayesian designs using informative priors	x
6	EFSPI / PSI Launch & Lifecycle Special Interest Group	EFSPI / PSI Launch & Lifecycle Special Interest Group	x
7	EFSPI / PSI HTA SIG	EU HTA – How can statisticians help navigate the problem of multiplicity?	x
8	EFSPI / PSI HTA SIG	What’s the HTA ESIG doing to prepare for EU HTA?	x
9	BBS Next Generation	Summary of BBS Next Generation Seminar: “Future of the Next Generation Statisticians and Quantitative Scientists”	x