Signal Management

In accordance with the German Medicinal Products Act (AMG) and the Guideline on Good Pharmacovigilance Practices (GVP), marketing authorisation holders are obliged, as part of their pharmacovigilance activities, to carry out signal detection and to promptly inform the competent higher federal authorities and the EMA about newly detected risks or a change in the benefit-risk profile of the medicinal product.

In order to support marketing authorisation holders specifically in fulfilling this obligation, with the database-based Signal Sentinel® we offer a powerful and at the same time efficient instrument for signal management.

Our signal detection tool Signal Sentinel® serves to simplify the capture, evaluation and documentation of signal detection processes and is used both in the initial report preparation and in the preparation of routine reports. You can use an active-substance-based subscription to receive pooled or individual signal detection reports as required.

Pooled report

As an editable, digital template, this Signal Sentinel® report includes, among others:

• Literature-based, active-substance-based report section
• Tabular presentation of the adverse reactions from literature reports
• Discussion of the published studies
• Line listing of the literature cases
• Research results on the active substance from authority websites
• List of sources as well as notes on the further processing of the report

Individual report

We prepare complete signal detection reports for you using the Signal Sentinel® method with:

• Direct reports, literature reports and authority reports
• Data from sponsored and published studies
• Signal validation, analysis, assessment
• Recommendations for action

Signal management SOP

The signal management SOP serves to ensure that the signal management for medicinal product risks of a medical nature carried out by MAHs or their contractors, and their evaluation and documentation, is performed according to a standardised procedure and in accordance with regulatory requirements in order to fulfil the pharmacovigilance requirements. By adhering to this SOP, signals indicating a change in the benefit-risk profile of a medicinal product can be detected and assessed in good time and appropriate measures can be initiated.