ICTA's pharmacovigilance department ensures the set-up and follow-up of all pharmacovigilance and medical device / materiovigilance activities related to clinical studies:
Management of pre and post-marketing clinical trials Pharmacovigilance, Materiovigilance and Biovigilance
Design / Consultancy / Review of the Safety documentation: protocol, safety management plans, clinical study reports…
EudraVigilance registration of Sponsors and of medicinal products in the eXtended EudraVigilance Medicinal Products Dictionary (XEVMPD)
Adverse Events (AEs) and Serious Adverse Events (SAEs) management including case review, PV database registration and follow-up, writing of narratives, reconciliation with clinical data base
Expedited Reporting of SUSARs to the Competent Authorities and Ethics Committees
Writing of Annual Safety Reports / DSUR / Vigilance Reports and transmission to the Regulatory Authorities
| A senior dedicated team including European QPPV (Pharmacists, Physicians and assistants) working with the support of the other ICTA departments. |  |