返回 Agenda
Moving Forward in EU Pharmacovigilance
Session Chair(s)
Brian Edwards, DrMed
Director
International Society of Pharmacovigilance, United Kingdom
This session will introduce delegates to new ways of evaluating evidence of our activities and apply new types of science for our sector based on systems theory. By thinking how patients can be part of the pharmacovigilance team we can out new ways of more effectively managing benefit-risk.
Learning Objective : Discuss ideas for describing the role and training needed for involving patients; Identify how to constructively criticize pros and cons of involving patients; Describe opportunities to apply systems theory to manage risk; Identify how evaluation of PRAC may help us more effectively manage risk.
Speaker(s)
System Analysis of UK Pregnancies Reported During and After Isotretinoin Administration
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Director
Patient Perspective
François Houyez
European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
Removal of Safety Concerns from EU-RMP: Lessons Learned from a Review of PRAC Meeting Minutes
Robert Massouh, MPHARM, RPH
GSK, United Kingdom
Head of Safety (PV) Risk Management and Benefit/Risk Evaluation