The purpose of this tutorial is to share knowledge and come up with some best practices between participants so that delegates leave the session better equipped and with an informal network of colleagues to tap into for working on the PSMF outside the EU.

Workshop Chairs:

Clare Lavery, Pharmacovigilance Excellence Principal, AstraZeneca, UK

Dionne Usher, Senior Specialist, EU QPPV Office, MSD, UK

Willemijn van der Spuij, EU Director Pharmacovigilance, PV Intelligence & International Operations, Bristol-Myers Squibb, Switzerland

Learning Objectives:

• Exploring the current PSMF landscape.
• Sharing of experiences and challenges across the world and discuss practical solutions to simplify work.
• Discuss and understand feedback received on existing PSMFs, sharing of strategies and processes.
• Encourage participants to work towards an approach that ensures compliance, good quality, simplification to deliver what is needed whilst eliminating duplication wherever possible

Audience:

PV/Industry experts involved in PSMF coordination and/or maintenance.

Level:

PV audience; beginners and advanced, trying to better understand the PSMF landscape and requirements around the globe.

Programme Agenda:

14:00 – Log-in and Connect
14:15 – Introduction and Welcome
14:25 – The current PSMF Landscape (Legislative Updates and recent Learnings)
15:15 – Workshop I: Audit and Inspections. Feedback on PSMFs and Lessons Learned
16:00 – Workshop II: Building your PSMF to allow global use (global, EU and Rest of World) – listing pros and cons of each approach with example of specific areas where there are questions (eg do you list vendor SOPs and contents of non-EU PSMFs)
17:00 – Workshop III: PSMF process and Oversight for QPPVs
17:45 – Workshop feedback
18:00 – End of Workshop