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KIT Royal Tropical Institute, Amsterdam

Oct 18, 2022 2:30 PM - Oct 20, 2022 1:00 AM

Mauritskade 63, 1092 Amsterdam, Netherlands

Global Clinical Trial Disclosure & Data Transparency Conference

Session 3: Perspective on How to Disclose Master Protocols and Estimands

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert

Merete-J Consulting, Denmark

Thomas  Schindler, PhD

Thomas Schindler, PhD

Director Global Regulatory Affairs - Regulatory Operations

BioNTech SE, Germany

Session 6: CTIS Case Studies

Speaker(s)

Merete  Joergensen, MBA, MSc

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

Thomas  Schindler, PhD

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

Rebecca  Williams, PharmD, MPH

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

Christine  Fletcher, MSc

Perspective on How to Disclose Master Protocols and Estimands

Christine Fletcher, MSc

GlaxoSmithKline, United Kingdom

VP/Head, Speciality and Primary Care Statistics

Robert  Hemmings, MSc

Estimands and Endpoints Reporting – How to Bridge the Gap?

Robert Hemmings, MSc

Critical Path Institute, United States

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