PRE-PROGRAM*

DAY 1 : February 24

16:40

Reusable models versus ad-hoc analyses

16:10

Three submitted communications

15:45

World models: what is coming, and the awareness gap

15:20

Break

14:55

Predict to prevent brain diseases’ progression : application to clinical trial design and patient identification

14:30

Synthetic data: utility, privacy and evaluation

14:05

Digital twin applications for increasing trial efficiency

12:30

Break

12:05

Impact on regulatory decision making and the lifecycle of uncertainty

11:40

Current practice: the US perspective and the global trends

11:15

QSP hybridised with AI

10:45

Break

10:20

AI-enabled external controls and Bayesian borrowing

09:55

Applied case studies from industry

09:30

Model-informed development: what qualifies as fit-for-purpose

09:00

Regulatory opening: where the agency stands

MORNING

AI-enabled evidence inregulatory and HTA practice today

AFTERNOON

Methods in the making

DAY 2 : February 25

11:00

How biostatistics evolves through systematic AI use

10:35

Three submitted communications

10:05

Break

09:40

RWE agencies will trust

09:15

What regulators could do with trial data, and why they have not

08:50

DARWIN EU: building the foundations for AI-enabled evidence generation

11:30

Data access as the binding constraint

12:00

Break

13:30

When AI writes the report: the inspection burden

13:55

Where LLMs help, and where they do not

14:20

Agentic AI, hybridisation and platforming

14:45

Break

15:00

Panel : The unmet needs: what no method answers yet

16:15

Closing remarks and outlook to 2028

MORNING

Data & biostatistics as the foundation

AFTERNOON

The generative turn and the regulatory response

* currently under development and subject to change.