In addition to assessing the efficacy of a treatment, all clinical trials aim to ensure that a treatment is safe for the health of the participating subjects.
The objective of the Pharmacovigilance Service for Clinical Studies, in accordance with the guidelines of Good Clinical Practice (GCP, E6 (R3)) and Good Pharmacovigilance Practice (GVP), is to quantify and qualify adverse events and all safety risks that arise during a clinical trial. This allows for the evaluation of the risk/benefit ratio of the investigational drugs and the communication of safety information to the relevant stakeholders (National Competent Authorities, EMA, Ethics Committees).
The main activities include:
- Analysis of reported adverse events
- Preparation of annual safety reports (DSUR)
- Notification of serious unexpected reactions to the EMA Eudravigilance portal
To ensure that these activities comply with current guidelines and legislation, the Pharmacovigilance Service, in collaboration with the Quality Assurance Service, drafts and updates standard operating procedures.
