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Session 1: Navigating the Windsor Framework - Implementation, Inspections, and Industry Insights
Session Chair(s)
Louise Woodward, PHD
UK QPPV and Local Safety Responsible
Roche Products Ltd, United Kingdom
Session overview: This session will delve into the key elements of the Windsor Framework, offering insights into its implementation and practical implications for QPPVs. Covering topics such as PSMF, PASS, and local RMPs, industry experts will share their experiences and engage with the audience to gather feedback on the post-Windsor Framework landscape. Attendees will also gain a comprehensive understanding of early inspection feedback from the MHRA and hear from industry representatives about unexpected challenges encountered during implementation. This interactive session will provide a valuable opportunity for discussion, reflection, and knowledge-sharing on the evolving regulatory environment.
Speaker(s)
Post-Windsor Framework: Industry Insights and Practical Experiences
Nicola Lawson
Jazz Pharmaceuticals, United Kingdom
Associate Director, EU/Int PV & QPPV Office, PV Intelligence and UK QPPV
Post-Windsor Framework: Industry Insights and Practical Experiences
Dionne Usher
Merck Sharp & Dohme Limited, United Kingdom
Associate Director, Office of the EU QPPV
Post-Windsor Framework: Industry Insights and Practical Experiences
Lauren East
Abbvie, United Kingdom
Head, Pharmacovigilance UK
Post-Windsor Framework: Industry Insights and Practical Experiences
Helen Fiddes
Bristol-Myers Squibb, United Kingdom
Head of Country Pharmacovigilance, UK and Ireland
Questions and Answers
Representative Invited