Safety and pharmacovigilance
At Aepodia, we provide pharmacovigilance services to help you meet the increasingly stringent pre- and post-marketing safety requirements. We work closely with you and your staff to meet your time constraints and quality requirement expectations.
Our solutions include:
- Medical expertise provided by EU Qualified Persons Responsible for Pharmacovigilance (EU QPPV);
- Electronic reporting of Individual Case Safety Reports (ICSR) using EVWEB;
- Creation of eXtended Eudravigilance Product Report Messages (XEVPRM) for authorised & investigational medicinal products using EVWEB;
- Periodic safety reporting: clinical trials Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSURs);
- Scientific casualty assessment and regular monitoring of benefit-Risk assessments;
- Pharmacovigilance System Master Files (PSMF);
- SAE coding, management and expedited reporting: collection, quality, control, assessment, narrative writing, unblinding and management of ICSRs;
- Identification of cases reported in published and scientific literature;
- Risk management plan development and summary descriptions of pharmacovigilance systems for marketing authorisation applications;.
- Review of the safety sections of promotional material;
- Ad hoc safety training of medical science liaisons, sales teams and administrative personnel;
- Pre-marketing vigilance services for all classes of medical device;
- 24/7 QPPV availability.