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Measuring of the Impact of Pharmacovigilance in the EU

Track:
What is the Future of Pharmacovigilance?

Day & Time:
April 18, 4:00PM - 5:30PM (Central Europe Standard Time)

Session Number:
S0503

Level:
Intermediate

Type:
Session

Title:
Measuring of the Impact of Pharmacovigilance in the EU

Chair(s):
Saad Shakir, MD
Director
Drug Safety Research Unit, United Kingdom

Description:
A project which involves PRAC, EMA and ENCePP brought together an extended team of experts to work on ways to measure the impact of pharmacovigilance. The session will provide information on the progress of the project with results.

Learning Objective(s):
1. Participants should be able to recall the reason why it is important to measure the impact of pharmacovigilance since the legislation was updated in 2012. 2. Participants should be able to explain the methods used to investigate the impact of pharmacovigilance

Presentation(s) & Speaker(s):
Measuring the Impact of Product Withdrawals and Other Major Pharmacovigilance Actions on the Public Health Burden in the EU
Saad Shakir, MD
Director
Drug Safety Research Unit, United Kingdom

Measuring the Impact of Pharmacovigilance Activities: Opportunities and Pitfalls
Agnes Kant
Nederlands Bijwerkingen Centrum Lareb, Netherlands

Introduction to the ENCePP Special Interest Group on Impact and an EMA perspective
Fergus Sweeney, PhD
Head of Inspections and Human Medicines Pharmacovigilance (Division)
European Medicines Agency, European Union, United Kingdom