Signal Management

Impact of Signal Management Activity on Risk-Benefit Balance

Signal Management is one of the critical processes in pharmacovigilance system. The overall objective for the set-up of Signal Management process is to identify the new potential risk or significant safety information or change in existing benefit-risk profile of the medicinal product and to provide a recommendation such as changes to the product information and/or other risk minimisation measures for the prevention of new safety signal or potential risk.

Frequency of Signal Management Activity

Frequency for the signal management activity shall be monthly / quarterly / six-monthly or annually based on the safety monitoring requirement of individual molecule.

Life Cycle of Signal Management Activity

Signal Management process includes the following activities:

Practical Challenges for Signal Management Activity

A signal management report or an outcome of routine signal management activity does not require submission to regulatory authority. However, MAH has an obligation to communicate with regulatory authority for any "emerging safety issue / significant safety issue / urgent safety issue" within 03 working days from the establishment of validated signal. Actual timeline for the submission of emerging safety issue to the regulatory authority may vary in different countries as per local requirement.

Likewise periodic safety report, Signal Management activity also requires a source data and scientific inputs from multiple stakeholders.

Our Solution for Complete Signal Management Activity

Considering the critical impact of an outcome of Signal Management activity, stringent timeline for its reporting for emerging safety issue, and process complexity due to involvement of multiple stakeholders, it makes the entire process of Signal Management activity a more challengeable particularly for the mid-to-complex size Global or Local Pharmaceutical Industry and Healthcare Organisation. Therefore, it is crucial to collaborate with a seasoned and trustworthy service provider like AllyWorth to secure the optimal regulatory compliance.