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Changes in PV and the Impact of EU PV Legislation on Patient Safety
Session Chair(s)
Jan Petracek, MD, MSc
CEO
Ivigee, Czech Republic
This session will consist of a presentation that will explore the impact on patient safety since the introduction of the PV legislation in the EU in 2012. Has the spirit of the legislation, as well as the requirements, made medicines safer for patients? What has the experience of patients, pharma and regulators been. Following a presentation, this session will be focusing on an open panel discussion that allows various stakeholders to share experiences and critically evaluate the evolution of the legislation.
Speaker(s)
A Decade Since the EUPV Legislation - The Spirit, the Ambition and the Impact on Patient Safety
Hubert Leufkens, PharmD, PhD
Utrecht University, Netherlands
Emeritus Professor of Pharmaceutical Policy and Regulatory Science
Panelist
Gilliosa Spurrier
MelanomeFrance, France
President of MelanomeFrance, Vice-President MNPE
Panelist
Sinead Curran, MS
HRB CRCI, Ireland
Quality and Regulatory Manager
Panelist
Jens-Ulrich Stegmann, MD, RN
GSK , Belgium
Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV
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