Talk Pharmacovigilance & Safety track
S0701 - Evolving Regulatory Landscape in PV
Tue, Mar 18, 2025 · 1:30–2:40 PM CET Sydney Room, Congress Center Basel
About this session
This session will delve into the dynamic changes within pharmacovigilance, focusing on the need for global consistency in safety reporting from clinical trials. It will address the shifting roles and professional growth of local patient safety professionals and their impact on the industry. The session will also present a collaborative model aimed at modernizing the management of Individual Case Safety Reports (ICSRs), fostering discussions on enhancing data management and regulatory practices.
Programme:
- Q&A
- 1. Regaining Global Alignment on Safety Reporting from Clinical Trials — Greg Ball
- 3. Evolving Local Patient Safety Professionals: Shaping the Future of Patient Safety — Begum Benli Peker
- 2. The First Step to a Multi-Stakeholder Collaboration to Modernize ICSR Management: A Model to Stimulate Meaningful Discussion — Lucinda Smith, Phil Tregunno
Speakers
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Deputy Director - Patient Safety Monitoring · Medicines and Healthcare Products Regulatory Agency (MHRA)
Speaker
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Director, Head of Patient Safety Netherlands & EU Hub · Bristol Myers Squibb
Speaker
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Executive Director, International Patient Safety, Europe · Bristol Myers Squibb
Chair
