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Monday, June 27 • 8:30am - 9:45am
#116: Has the EU Good Pharmacovigilance Practices Delivered on Its Intended Promise and Commitment?

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Limited Capacity seats available

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.


Valerie E. Simmons, MD, FFPM


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

avatar for Valerie Simmons

Valerie Simmons

EU QPPV, Global Patient Safety, Eli Lilly and Company Ltd
Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. | Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Committee, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks... Read More →

avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Risk Management, Real World & Late Phase Research, Quintiles Inc.
Currently VP and Global Head of risk management at Quintiles, Dr Blackburn worked in pharmacovigilance at the European Medicines Agency for almost 17 years. She developed the EMA's risk management policies and strategy for Europe and was the lead author of the European guidelines. Prior to this she worked in the pharmaceutical industry and hospital medicine. She originally co-developed the course in PhV and PhEPi at LSHTM where she is Hon... Read More →

Leonardo Ebeling

General Manager, Dr. Ebeling & Assoc. GmbH
Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions. In 1998, Dr. Ebeling launched his CSO company providing drug safety services in medical science, pharmacovigilance, risk management and regulatory affairs... Read More →

Monday June 27, 2016 8:30am - 9:45am
103C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA