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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, RPh
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)
Introduction to the Session and New Themes in EU-GVP Module XVI
Priya Bahri, PhD, RPh
European Medicines Agency, Netherlands
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy)
Overview of Key Changes of the GVP XVI: How Will the Industry Adjust? 5 Key Areas Where Industry Has to Scale Up
Klaudija Marijanovic Barac, MD
Teva, Croatia (Hrvatska)
Senior Director, Teva Periodic Reports and Risk Management Centre
Target Audience Feedback: How to Engage for User Testing
Raluca Negricea, MPharm, MSc, RPh
Roche, United Kingdom
Associate Safety Director
Challenges of Implementing and Measuring Effectiveness of Risk Minimisation Measures
Kate Bendall
Axian Consulting Limited, United Kingdom
Head of Implementation
Learning from the Social Sciences - Formative Methods for Pharmaceutical Risk Minimisation and Patient Safety
Patrick Brown, PhD, MA
University of Amsterdam, Netherlands
Associate professor
Panelist - PRAC
Sabine Straus, MD, PhD, MSc
Medicines Evaluation Board (MEB), Netherlands
PRAC Chair, Staff Member
Panelist - Healthcare Perspective
Roberto Frontini
Centre for Patient Safety Leipzig, Germany
Director of Pharmacy
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