Signal Management

We offer a reliable and centralized system to track signals, ensuring all safety actions are reconciled in a standard manner, independent of therapeutic category or geography. Our signal management principle is based on:

1. A robust signal detection and validation process
2. Timely analysis and prioritization of all relevant data
3. A risk-based but proportionate approach in signal assessment
4. Recommendation for action
5. Communication.

We review various sources of information including ICSRs, EVDAS, FAERS, FDA Sentinel Analyses from ARIA, WHO’s VigiBase, Health authority websites etc. Our multidisciplinary teams have designed, implemented and overseen compliant signal detection and management processes for over 650 INNs throughout the lifecycle of medicines and have identified safety patterns emanated from AR data suggesting new safety information for medicines including fixed combinations.

These processes have:

• Involved accurate source selection ranging from medical literature and social media to observational studies and clinical trials/investigations; all scientific information pertinent to the use of products is screened, such as:
  • medicinal products – quality, non-clinical, clinical, pharmacovigilance and pharmacoepidemiologic data, and
  • devices e.g., spontaneous reports found in MAUDE, provide early warning of potential issues
• Facilitated clinical trial updates through safety related protocol amendments, safety revisions in the PIS/ICF and the IB (RSI), with the collaboration of our safety and medical writers and confirm or reject potential or identified risks
• Enabled regulatory compliance, so for example validated signals have been reported as standalone notifications, through submission of safety variations and/or within PSURs
• Provided an adequate and tailored system set-up, which has been manifested by PrimeVigilance’s excellent inspection outcomes, from EU and ex-EU authorities
• Ensured that requests from regulatory bodies, e.g., submission of an ad-hoc PSUR recommended by PRAC or a recommendation to conduct a PASS, are tracked in a timely manner.