8th EFSPI Workshop on Regulatory Statistics 2023

Location:
Face-to-face meeting in Basel, Switzerland

Dates and times (CET):

Wednesday, 13th September 2023, 9-17 (+ 2h wine tasting)
Thursday, 14th September 2023, 9-18

Description:
EFSPI 8th Regulatory Statistics Workshop - The workshop will discuss opportunities and challenges of statistical topics between regulators, academics, and industry.

For more information about the workshop - Click Here

Presentations

	Rochon
	Schiel
	Roes
	Akacha
	Bornkamp
	Schiel.2
	Haering

	Framke
	Viberg
	Senn
	Klinglmueller
	Ray
	Chakravarty
	Johnston
	Sridhara
	Bretz

Jasvinder Singh opted out of slide posting and being recorded.

Posters

	Estimands in Oncology
	Is medical affairs the wild west of statistics?

Recording

DAY 1

1. Introductory Keynotes: Regulator on "What happened in the last two years in regulatory and HTA landscape"
2. Q&A and discussion of morning session
3. Postbaseline subpopulation analyses: Known to be improper, but frequently done. Can we fix them?

DAY 2

1. Regulators and HTA bodies for new designs in Europe - how to deal with different priorities, especially for new design types?
2. Generalizability and external validity: How to generate evidence about a treatment effect?
3. Role of statistics / quantitative science in regulatory decision-making
4. Short topic session & Closure