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Monday, June 24 • 11:00am - 12:00pm
#106: Moving Forward in EU Pharmacovigilance

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-523-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Brian Edwards, DrMed


System Analysis of UK Pregnancies Reported During and After Isotretinoin Administration
Brian Edwards, DrMed

Patient Perspective
François Houyez

Removal of Safety Concerns from EU-RMP: Lessons Learned from a Review of PRAC Meeting Minutes
Robert Massouh, MPharm, RPh

avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for François Houyez

François Houyez

Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURODIS), France
François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access, Policy Advisor. He has always been working as a patient advocate since the early 90s, first in the HIV/AIDS advocacy, and in rare diseases... Read More →

Robert Massouh

Risk Management Product Lead, Pfizer Ltd
Robert is a Risk Management Product Lead at Pfizer, supporting the development and execution of Risk Management strategies for Pfizer products. He was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Robert is a registered Pharmacist... Read More →

Monday June 24, 2019 11:00am - 12:00pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics Regulator Thinking,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum