×
Back to Agenda
Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework
Session Chair(s)
Marian Mitroiu, PHD
Associate Director Biostatistics, Biogen, Switzerland
This session will include short presentations delivered by speakers from three Regulatory Agencies sharing perspectives based on their own experience with the ICH E9(R1) estimand framework implementation. The session participants will have the opportunity to engage with the speakers in a 25-minute open discussion, fueled by a few survey questions.
Learning Objective : Highlight how scientific questions of interest from different stakeholders require different strategies for the intercurrent event of new anti-cancer medication; discuss implications for the trial design and decision-making; emphasize the importance of the specific mechanism bringing about the hypothetical scenario, when determining whether the use of a hypothetical strategy is reasonable. Illustrate how in some settings the use of a hypothetical scenario may not be appropriate.
Speaker(s)
Francesco Pignatti, MD
Scientific Adviser for Oncology, European Medicines Agency, Netherlands
EMA Update
Cesar Daniel Torres, PHD, MS
Senior Mathematical Statistician, OB, OTS, CDER , FDA, United States
FDA Update
Laura Rodwell, PHD
Statistical Assessor, Dutch Medicines Evaluation Board, Netherlands
MEB Update
Have an account?