The South African Health Products Regulatory Authority (SAHPRA) invites all holders of certificates of registration (HCRs) and clinical research organisations (CROs) responsible for submitting adverse events (AEs) and/or serious adverse events (SAEs) to a consultation meeting on the implementation of the industry e-reporting platform, Vigiflow.
Purpose
This meeting will provide HCRs with an opportunity to seek clarification on the submission of postmarketing AEs through the industry e-reporting Vigiflow platform and introduce the use of a similar Vigiflow reporting tool for submitting SAEs during clinical trials.
Industry e-reporting is a web-based tool that allows HCRs/ applicants or CROs to submit individual case safety reports (ICSRs), adverse events following immunisation (AEFIs), and SAEs directly to SAHPRA’s national database through an external interface, using the international standardised format.
Discussion points
1. Overview of the industry e-reporting Vigiflow platform and the submission of reports through the portal.
2. Accessing the industry e-reporting Vigiflow platform.
3. Introduction to the use of the industry e-reporting Vigiflow platform for reporting SAEs during clinical trials.
Register here
Download the agenda
here.
