Safety and Pharmacovigilance
Drug safety is an obligatory ethical and procedural function which always comes first, therefore, a thorough and complete pharmacovigilance system implemented throughout the clinical and post-marketing phases is essential for the protection of patients and public health.
ANTAEA provides Pharmacovigilance services in the Region, in the context of Interventional Clinical Trials/ Non Interventional Trials as well as Post-Marketing period, employing specially trained and accredited personnel. These services include:
- Collection of Adverse Events
- Reporting/ Submission of Adverse Events/SUSARs to Respective Authorities
- Electronic Reporting of ICSRs in the EEA
- Submission of Periodic Reports/ DSURs
- PVG Consulting in regards to consistency with applicable local requirements/ legislation
