Based on presentations by the European Medicines Agency (EMA), it is expected that in the 4th quarter of 2017, Marketing Authorization Holders (MAHs) in Europe will be required to identify, validate and monitor signals from the EudraVigilance Data Analysis System (EVDAS). Safety teams will be obligated to access EVDAS and use the electronic Reaction Monitoring Report (eRMR) and other tools to perform signal detection from EVDAS.
Commonwealth eRMR Readiness Services are designed to support safety teams in meeting the new European requirements and using this change as an opportunity to optimize their overall signal management process. Our team of signal detection experts and IT professionals will work with safety teams to:
- Review and update signal management process
- Support and train staff on new procedures
- Optimize signal management process while incorporating new requirements
- Access CVW to identify, investigate and track signals from EVDAS efficiently
- Provide quantitative signal detection expertise to support interpretation and further analysis of EVDAS signal scores.
- Rapid Compliance – Rapid and effective training of safety staff by an experienced team that supports regulator and industry signal management systems and safety databases.
- Reduced Costs – The expert Commonwealth team and product portfolio allows customers to comply with the new legislation without adding new systems, people or infrastructure
- Reliable Results – Access to Commonwealth Vigilance Workbench (CVW) to efficiently identify, investigate, and track EVDAS scores, and the possibility to integrate other signaling sources for comparison.
For a complete recommendation and demonstration of how eRMR Readiness Services can be applied to your products, contact us.