Slidedecks and recordings will be continuously added as soon as we have them and the presenter’s consent.
Download all materials as .zip file
Recordings
Recordings of those sessions where all presenters have given consent:
Slidedecks and posters
Session 1: Regulators Question, Industry Answers: An Interactive Panel Session
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | John Aspegren with Tommi Nurminen and Elina Asikanius (fimea, FI) | Changes to ongoing open-label clinical trials | x |
| 2 | Armin Schüler (BfArM, DE) | Bridging the clinical–statistical divide | x |
| 3 | Laura Rodwell (Medicines Evaluation Board, NL) | Relationship status: It’s complicated | x |
Session 2: Engaging Regulators: Industry Questions and Regulatory Insight
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Diane Uschner (Roche, CH), Olga Kuznetsova (Merck), Johannes Krisam, Kerstine Carter (BI), and Alex Sverdlov (Novartis) | Randomization in clinical trials: statistical advancement and regulatory acceptance | x |
| 2 | Tobias Mütze, Mouna Akacha, and Frank Bretz (Novartis, CH) | Statistical details in the protocol: how much is enough? | x |
| 3 | Baldur Magnusson (UCB, CH) and Marcel Wolbers (Bayer, CH), on behalf of all contributors (EFPIA/EFSPI EIWG estimation sub-team and colleagues) | Composite strategies for continuous endpoints: failure values or failed question? | x |
| 4 | Martin Kappler (Cytel, FR) and Emmanuel Zuber (Cogitamen, CH) | Conditional marketing authorization and testing strategy on a single pivotal trial | x |
| 5 | Xin Luo (Pfizer, NO), Maria Kudela (Pfizer, US), and Margaret Gamalo (Pfizer, US) | Real-time trials and unfinished rules: keeping up with the science | |
| 6 | Achille Demares, Kelly Van Lancker, and Stijn Vansteelandt (Ghent University, BE), Hege Michiels, Els Coart, Fien Gistelinck, and Efi Gymnopoulou (argenx, BE) | Delayed-start design: enabling placebo-controlled comparative analysis |
Session 4: Draft EMA Guideline on Non-Inferiority and Equivalence: Key Updates and Stakeholder Perspectives
Session 5: Development of patient relevant and sensitive endpoints – opportunities for statisticians
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Susanne Clinch (Roche, UK) | Identifying relevant disease domains in heterogeneous syndromes: Angelman syndrome case study | x |
| 2 | Laurent Servais (University of Oxford, UK) | SV95C: from EMA qualification in Duchenne to application in other conditions | x |
| 3 | Taco B.M. Monster (Medicines Evaluation Board, NL) | Regulatory view on qualification of novel endpoints | x |
Session 6: From first wave to future practice: learning from early Joint Clinical Assessments procedures
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Antje Behring (Leonardo Symphony, DE) | From PICO to assessment report: navigating uncertainty and evidence gaps | x |
| 2 | Lars Beckmann (IQWiG, DE) | Experiences from the first JCAs: data presentation, indirect comparisons, and risk of bias | x |
| 3 | Thomas Ecker (Ecker + Ecker, DE) | Navigating JCA: where are we at month 20? | x |
Session 7: Aligned at Baseline? Closing the Gaps on Baseline Covariate Adjustment
Session 8: Synthetic Data in Biostatistics: Definitions, Regulatory Implications, and Practical Applications
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Andrea Manfrin (MHRA, UK) | Use of synthetic data in clinical trials: overcoming limitations of standard clinical trials | x |
| 2 | Federico Mattiello, and Francesco Brizzi (Roche, CH) | Use of synthetic data in clinical trials: overcoming limitations of standard clinical trials | x |
Posters
| Talk | Speaker and affiliation | Talk title | Download (if available) |
|---|---|---|---|
| 1 | Robbie Peck | Shape the next generation of quantitative scientists | |
| 2 | Christian Schmid | CMC SIG at a glance: purpose and key milestones | |
| 3 | Nicolas Sauvageot, Samantha Hinsley (Chair), Marie-Karelle Riviere (Co-Chair) | New ESIG on the block: introducing the Early Phase ESIG | x |
| 4 | Ulrike Fischer, Karen Muhs, Edith Küpper, R. Maarten van Dijk (all Staburo) | Estimand implementation in the EU Clinical Trial Register CTIS: are we there yet? | x |
| 5 | Arthur Allignol, Orlando Dohring, Min-Hua Jen, Sutish Kumar, Katrin Kupas | Working together to shape the future of evidence for HTA and JCA | |
| 6 | Orlando Dohring, Rima Izem, Min-Hua Jen, Iftekhar Khan, Josephine Wolfram | Synthetic data for HTA and real-world evidence: overcoming data constraints | |
| 7 | Cornelia Dunger-Baldauf | Launch & Lifecycle eSIG | |
| 8 | Michael Mader, Wilmar Igl, Martin Fahy, Emilie Gérard, Rada Ðakovic | Statistical challenges and regulatory landscape in medical device development | x |
| 9 | Alex Ocampo, Nuala Peter, Patrick Schlömer, Vivian Lanius | EFSPI/PSI Multi-component Endpoints SIG | x |
| 10 | Diane Uschner | Randomization Working Group: bridging statistical innovation and clinical trial practice | |
| 11 | Fredrik Öhrn, Christoph Gerlinger | EFSPI/PSI Regulatory European Special Interest Group | x |
| 12 | Josie Wolfram, Eleanor Ralphs, Rima Izem | EFSPI/PSI Real World Data SIG | |
| 13 | Daniele Bottigliengo, Ellie Grainger, Jonas Haggstrom, Alexandra James, Axel Krebs-Brown, Emmanuel Pham, Fabio Rigat, Pierre Verweij, Anna Wiksten | EFSPI Scientific & Training Academy |