戻る Agenda
Session 1: Introduction
Session Chair(s)
Jim Slattery, MSC
Statistician, Pharmacovigilance Department
European Medicines Agency, Netherlands
Controlled clinical trials are considered as gold standard in drug development and this session will explore the potential role of observational evidence in a regulated environment. Taking the totality of evidence into account in a systematic way for decision making at all stages of drug development, the session discusses innovative approaches to combine information from randomised trials and observational studies. Observational data may be considered the best available / achievable information in a number of situations; recent examples and experiences for the use of observational data will be presented.
Speaker(s)
Need for Observational Evidence
Anja Schiel, PHD
Norwegian Medical Products Agency (NOMA), Norway
Special Advisor, Lead Methodologist/Statistician; NOMA
What Do We Need to Be Able to Do to Formalise Use of Observational Evidence?
Robert Hemmings, MSC
Critical Path Institute, Netherlands
FDA Priorities and Action Plan Regarding Observational Data
Mark Levenson, PHD
FDA, United States
Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER