3rd EFSPI Workshop on Regulatory Statistics

Date:
24 - 25th September 2018

Location:

Oekolampad Church Allschwilerplatz 22 CH – 4055 Basel Switzerland

Description:
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 Click Here

Presentations

	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?
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	Regulatory experience with regard to submissions that include modelling and simulation
	Uncertainty in Benefit-Risk Assessment