3rd EFSPI Workshop on Regulatory Statistics


24 - 25th September 2018


Oekolampad Church Allschwilerplatz 22 CH – 4055 Basel Switzerland

The 3rd regulatory statistics workshop took place in Basel on 24th and 25th September 2018. You will find the flyer and presentations from the successful meeting below.

For the event program please
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ICH E9(R1): Status of addendum and comments
Efficacy independent of relapse HA interactions before ICH E9 R1
Need for Treatment strategy as an estimand attribute
Trimmed mean to handle missing/meaningless outcomes - a recommendation from FDA
Estimands for Recurrent Event data
Efficiency comparisons of recurrent event and time-to-first event analysis
Group Sequential designs for recurrent events.
Regulator’s view on estimands for time-to-event data
Master protocols: MHRA experience
European regulators’ view on platform trials
Master Protocols – FDA Oncology Experience
When a Threshold Crossing approach may and may not be appropriate.
Complementing evidence from a small scale RCT by registry data in a rare disease setting
Regulatory considerations when supplementing confirmatory RCTs with non-randomised external data
HTA considerations when supplementing RCT with non-randomized data
Model-based extrapolation between dosing regimens
Testing treatment effect when hazards are non-proportional
Is adherence to placebo control sometimes doing a disservice to both current and future patients?
Regulatory experience with regard to submissions that include modelling and simulation
Uncertainty in Benefit-Risk Assessment