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