Pharmacovigilance Conference 2017

Changes in pharmacovigilance activities in and outside Europe have prompted new challenges for all stakeholders. Methodologies used in risk management are evolving and becoming increasingly accurate in addressing potential and identified risks. Join the Pharmacovigilance Conference to discuss paths forward and formulate answers to key questions: 1.Benefit-risk assessment - What and how to do in practice? 2.What are the key pharmacovigilance inspection trends, plus options for improving organisation and processes - including the role of the EU QPPV and the Pharmacovigilance System Master File (PSMF)? 3.What progress and insights have been made within new EU project WEB-RADR on pharmacovigilance and social media? 4.What are the current regulatory and practical challenges of the Risk Management Plan and can potential improvements be identified? 5.How do the latest Pharmacoepidemiological approaches support risk management? The conference format is designed to generate dialogue and solutions through a series of interactive sessions. Discussion content will be tailored on the basis of questions raised in advance by attendees. Day 1: Workshops and Feedback sessions dedicated to collaboration with experts and colleagues on differing approaches to the implementation of the regulation changes Day 2 Morning: Interactive Presentations on Risk Management and Pharmacovigilance Plans Day 2 Afternoon: Workshop on Risk Minimisation Measures, with several experts from industry, academia and regulatory authorities convening to discuss the current issues and propose different approaches