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Session 2, Track C: From Duplication to Innovation: Modernizing ICSR Collaboration
Session Chair(s)
Mei Lam, BSN, RN
Associate Director Consumer Safety Regions Americas
Haleon, Canada
Ricardo Pasquel Cook, MD
Safety Team Lead
Pfizer Inc., Canada
This session presents a forward-looking conceptual model aimed at transforming how Individual Case Safety Reports (ICSRs) are managed across the pharmacovigilance ecosystem. It tackles the critical challenges of data duplication and inefficiency, proposing a collaborative, multi-stakeholder approach involving regulators, marketing authorization holders, and global experts. Attendees will explore how this model can enhance data quality, streamline safety surveillance, and support the launch of a scalable pilot initiative.
- Multi-Stakeholder Collaboration to Modernize ICSR Management: A Model for Meaningful Discussion
Clint Craun, TransCelerate BioPharma, Inc. - From Duplication to Innovation: Modernizing ICSR Collaboration
Laura Muranyi, Health Canada
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand and summarize the proposed ICSR model and its implications for global regulatory harmonization
- Identify the technical or regulatory barriers to implementing reduced ICSR replication
- Evaluate the potential of the proposed model to improve data quality, streamline safety surveillance processes, and support the development of a scalable pilot initiative
Speaker(s)
From Duplication to Innovation: Modernizing ICSR Collaboration
Laura Muranyi
Health Canada, Canada
Manager, Health Products Surveillance and Epidemiology Bureau
Multi-Stakeholder Collaboration to Modernize ICSR Management: A Model for Meaningful Discussion
Clint Craun, MA
Transcelerate Biohparma, United States
Program Director
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