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Risk Minimisation Measures: Future Collaborative Solutions in Europe
Session Chair(s)
Mark Perrott, PHD
Managing Partner, Axian Consulting Ltd., United Kingdom
Priya Bahri, PHD
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
In 2024, risk mininisation guidance in the EU will change as GVP XVI is revised, shifting the landscape based on implementation science. This session will first hear from a regulatory leader, followed by industry reflections. With both perspectives provided, insights from a leading academic will be shared and risk minimisation contextualized at the local level by a member of PRAC. Finally, the session will close by looking at how risk minimization measures can be implemented in a healthcare system.
Speaker(s)
Priya Bahri, PHD
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Introduction to the Session and New Themes in EU-GVP Module XVI
Klaudija Marijanovic Barac, MD
Senior Director, Teva Periodic Reports and Risk Management Centre, Teva, Croatia
Overview of Key Changes of the GVP XVI: How Will the Industry Adjust? 5 Key Areas Where Industry Has to Scale Up
Raluca Negricea, MPHARM, MSC, RPH
Associate Safety Director, Roche, United Kingdom
Target Audience Feedback: How to Engage for User Testing
Kate Bendall, DRSC
Head of Implementation, Axian Consulting Limited, United Kingdom
Challenges of Implementing and Measuring Effectiveness of Risk Minimisation Measures
Patrick Brown, PHD, MA
Associate professor, University of Amsterdam, Netherlands
Learning from the Social Sciences - Formative Methods for Pharmaceutical Risk Minimisation and Patient Safety
Sabine Straus, MD, PHD, MSC
Former PRAC Chair, Medicines Evaluation Board (MEB), Netherlands
Panelist - PRAC
Roberto Frontini
Former Director of Pharmacy, Centre for Patient Safety Leipzig, Germany
Panelist - Healthcare Perspective
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