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Session 3: Perspective on How to Disclose Master Protocols and Estimands
Session Chair(s)
Merete Joergensen, MBA, MSC
Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark
Thomas Schindler, PHD
Director Global Regulatory Affairs - Regulatory Operations, BioNTech SE, Germany
Session 6: CTIS Case Studies
Speaker(s)
Merete Joergensen, MBA, MSC
Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark
Simplified Approach to the Concept of Estimands - What and Why it is Important to Specify Estimands
Thomas Schindler, PHD
Director Global Regulatory Affairs - Regulatory Operations, BioNTech SE, Germany
Simplified Approach to the Concept of Estimands - What and Why it is Important to Specify Estimands
Rebecca Williams, PHARMD, MPH
Senior Clinical Trials Subject Matter Expert, Essex Management, Part of Emmes Group, United States
Approach for Reporting Master Protocol Study Designs on ClinicalTrials.gov
Christine Fletcher, MSC
VP/Head, Speciality and Primary Care Statistics, GlaxoSmithKline, United Kingdom
Perspective on How to Disclose Master Protocols and Estimands
Robert Hemmings, MSC
, Critical Path Institute, Netherlands
Estimands and Endpoints Reporting – How to Bridge the Gap?
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