Join TransCelerate BioPharma for a presentation and panel discussion on our Individual Case Study Report (ICSR) Replication Paper. The article is the first quantification of the phenomenon of ICSR replication across Health Authority and marketing authorization holder safety databases. It presents a first-of-its-kind illustration of the diverging case information that can exist across data repositories. The webinar includes:
- A presentation of the analysis that quantifies the amount of ICSR replication within the pharmacovigilance (PV) ecosystem.
- A panel discussion of the value of reducing the duplicative, replicated ICSR-related activities and the impact of that reduction on patient safety and prompting discussions about mitigating regulatory and technical approaches.
Watch the webinar from the button above. The presentation slides can be accessed here.
Panelists:
- Andrew Bate, Vice President & Head, Safety Innovation & Analytics Global Safety, GSK
- Vijay Kara, Director, Safety & Quantitative Innovation, Safety Innovation & Analytics, Global Safety, GSK
- David Lewis, Head QPPV PRRC Office, Novartis; Visiting Professor, School of Live & Medical Sciences, University of Hertfordshire
- Phil Tregunno, Deputy Director, Patient Safety Monitoring, MHRA
- Florence Van Hunsel, Senior Epidemiologist, Lead Safety Innovation, Netherlands Pharmacovigilance Centre Lareb
- John van Stekelenborg, Senior Director, Methods & Analysis, J&J
Ideal Attendees:
- ICSR Reporting and Transmission Professionals
- PV Database Administrators
- PVA Managers and Execution/Implementation
- PV Functional Representatives from Safety Departments
- PV Operations
- Health Authorities (HAs)
- Marketing Authorization Holders (MAHs)
TransCelerate webinars may be recorded in whole or in part.