戻る Agenda
EU Update: PROTECT and EnCePP
Session Chair(s)
Stella Blackburn, MD, MA, MSC, FFPM, FISPE, FRCP
Strategy
Consultant, United Kingdom
Triage Strategies for Screening Longitudinal Observational Databases
Learning Objective : Discuss the multi-disciplinary approach adopted by the EMA to improve the BR assessment of medicines;Identify the core principles of scientific excellence, independence and transparency introduced by EU regulators and academic community for the conduct of postauthorization studies on safety and BR;Describe the main methods for BR integration and visualization and how they perform in real life case studies.
Speaker(s)
Benefit-risk Integration and Representation: Results From PROTECT
Diana Hughes, MD
Pfizer Inc, United States
Vice President, Worldwide Safety
Triage Strategies for Screening Longitudinal Observational Databases
Niklas Noren, PHD, MSC
Uppsala Monitoring Centre (UMC) , Sweden
Chief Science Officer
ENCePP: Strengthening Methodology, Transparency and Independence
Stella Blackburn, MD, MA, MSC, FFPM, FISPE, FRCP
Consultant, United Kingdom
Strategy