Signal Detection and Management (including EVDAS)
Pharmacovigilance
Proactive signal detection and management is essential for maintaining the safety profile of medicinal products and meeting global pharmacovigilance obligations. Regulatory authorities such as the EMA and FDA expect MAHs to continuously monitor safety data and act promptly on emerging risks.
PVpharm combines regulatory expertise and medical evaluation to support proactive signal detection and management, including the use of EudraVigilance Data Analysis System (EVDAS), internal databases, and literature sources.
Our services include:
- Routine Signal Detection: Analysis of safety data from EVDAS, internal databases, and other sources.
- Signal Validation & Assessment: Medical review and evaluation of potential safety signals.
- Signal Management Documentation: Preparation of Signal Identification Reports (SIRs) and regulatory submission.
- PRAC and EMA Interaction Support: Assistance in responding to regulatory authority queries and requests.
