Signal management
Signal Sentinel®
As part of their pharmacovigilance activities, marketing authorization holders are obliged under the German Medicines Act (AMG) and the Guideline on Good Pharmacovigilance Practice (GVP) to provide signal detection and immediate information to the competent higher federal authorities and the EMA about newly discovered risks or a change in the benefit-risk profile of the medicinal product.
In order to specifically support marketing authorization holders in fulfilling this obligation, we offer the database-based Signal Sentinel®, a powerful and efficient signal management tool.
Our signal detection tool Signal Sentinel® is used to simplify the recording, evaluation and documentation of signal detection processes and is used both for initial reporting and for the creation of routine reports.
You can use an active substance-related subscription to receive pooled or individual signal detection reports as required.
Pooled report
This Signal Sentinel® report includes an editable digital template:
- Literature-based, active substance-related report section
- Tabular presentation of side effects from literature reports
- Discussion of the published studies
- Line listing of literature cases
- Research results on the active ingredient of government websites
- List of sources and notes on the further processing of the report
Individual report
We create complete signal detection reports for you using the Signal Sentinel® method with
- Direct reports, literature reports and official reports
- Data from sponsored and published studies
- Signal validation, analysis and evaluation
- Recommended measures
Signal management SOP
The signal management SOP serves to ensure that the signal management for drug risks of a medical nature carried out by MAHs or their contractors, their evaluation and documentation for the fulfillment of pharmacovigilance requirements is carried out according to a uniform procedure and in accordance with regulatory requirements.
By adhering to this SOP, signals that indicate a change in the benefit-risk profile of a medicinal product from a company can be recognized and evaluated in good time and appropriate measures can be initiated.
