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