DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The session will review the implementation status of the 2010 EU Pharmacovigilance Legislation and its associated Good Pharmacovigilance Practices Guidelines, focusing on the key challenges and uncertainties arising from implementation, as well as some future proposals to measure impact on facilitating the performance of pharmacovigilance in the European Union. Did it do what it originally set out to achieve? Key to the success of implementing a robust pharmacovigilance system is the ability to strengthen the monitoring of benefit risk throughout a products life cycle. The results of the PROTECT work stream that arose as a quantum leap forward in benefit risk evaluation from the Innovative Medicines Initiative in the EU will be explored and how the results have changed industry and regulatory authority standards.

Learning Objectives

Discuss the current status, challenges, and uncertainties arising from the implementation of the EU Good Pharmacovigilance Practices Guidelines associated with the 2010 EU Pharmacovigilance Legislation; Describe future strategies to measure the impact that the legislation and guidelines have had since implementation; Explore how the results of PROTECT have changed industry and regulatory standards.

Chair

Valerie E. Simmons, MD, FFPM

Speaker

Introduction, General Overview of Implementation of the EU GVP Guidelines: Did They Actually Deliver?
Valerie E. Simmons, MD, FFPM

IMI PROTECT: Challenges, Successes, and the Effect on PhV in Europe
Stella C.F. Blackburn

Important Risks Resulting from EU PV Legislation and Guidance: Best Practice to Allow Optimized Patient Safety?
Leonardo Ebeling