4th EFSPI Workshop on Regulatory Statistics

Date:
23rd - 24th September 2019

Location:

Oekolampad Church Allschwilerplatz 22 CH – 4055 Basel Switzerland

Description:
After three very successful workshops on regulatory statistics in the past three years, EFSPI is pleased to announce the 4th regulatory statistics workshop taking place in Basel on 23rd and 24th September 2019

For the event program please Click Here

Presentations

	Real World Data, Real World Evidence, Big Data
	BBS spring seminar on synthetic controls: summary & follow-up
	Development of a digital endpoint in Multiple Sclerosis -challenges and opportunities
	A look on Best Practices in Pragmatic Trials
	One single arm study plus a historic comparator equals two historic regulatory approvals
	Development of a smartphone based monitoring tool for people with Multiple Sclerosis Challenges and Opportunities
	Using Real-World Data to Extrapolate Evidence from Randomized Controlled Trials
	Use of RWD in gene - therapy approvals
	Use of historical data to support gene-therapy approval: example from Kymriah
	How far can we trust “Real World Data”?
	Comparison of statistical methods to analyse safety data
	Pooling and harmonizing of safety data for a robust statistical analysis
	A shiny app to explore clinical data
	Matching up
	How statisticians deal with the difference between efficacy and safety reporting
	How the estimand framework becomes standard practice in applications, and where we still need to learn
	Treatment policy and hypothetical strategies for intercurrent events in chronic pain and Parkinson’s disease
	Estimand framework: opportunity to rethink some old (and new) problems in Oncology trials?
	Regulatory experience with the Estimand framework
	Observational vs. randomized analysesof digoxin-mortality in the DIG trial
	Goal Attainment Scaling: Validation & use for rare disease
	A regulator’s view on rare cancer drug development: Histology independent indications
	Masking of open label studies
	To blind or not to blind? FDA guidance on placebos and blinding in oncology clinical trials
	Underpowered RCTs and external data
	EMA (2018) Q&A on Mahalanobisdistance (MD) to assess drug dissolution profiles