Challenge
*** The Module is applicable to medicinal products for human use authorised in the EU irrespective of the authorisation procedure (centralised or national procedure, including mutual recognition and decentralised).
Solution
Developed a new IT System that ensures consistent tracking of safety signals and risks, with signal validation, evaluation steps and decision making processes.
The solution was build to reduce the number of applications used for safety signals management.
The application contains a repository where all safety signals, actions and documentations related to the signal management process are stored.
The application presents a Reporting section where users can generate:
- Periodic reports for signal detection and evaluation
- Periodic extracts of signals created or updated for Pharmacovigilance awareness
- Various reports of QC and compliance
Results
The solution is successfully used by more than 300 users in France and United States of America. It reduced the time to create and process safety signals. User experience was improved:
- Users are working in one centralised application. Before they had to use multiple systems in order to create, manage and track safety signals.
- Users receive periodic reports sent automatically by the system. Before they had to generate each report by hand and accessing different systems.
- Users have the option to configure the Notification process and reports.