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X-WR-CALNAME:SAHPRA
X-ORIGINAL-URL:https://www.sahpra.org.za
X-WR-CALDESC:Events for SAHPRA
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TZID:Africa/Johannesburg
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DTSTART:20250101T000000
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BEGIN:VEVENT
DTSTART;TZID=Africa/Johannesburg:20260804T140000
DTEND;TZID=Africa/Johannesburg:20260804T160000
DTSTAMP:20260803T125404Z
CREATED:20260803T125318Z
LAST-MODIFIED:20260803T125404Z
UID:20136-1785852000-1785859200@www.sahpra.org.za
SUMMARY:SAHPRA's Industry Consultation on e-Reporting VigiFlow Platform
DESCRIPTION: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.\n\n\n\n\nPurpose\nThis 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.\n\nIndustry 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.\n\n\n\n\nDiscussion points\n1. Overview of the industry e-reporting Vigiflow platform and the submission of reports through the portal.\n2. Accessing the industry e-reporting Vigiflow platform.\n3. Introduction to the use of the industry e-reporting Vigiflow platform for reporting SAEs during clinical trials.\n\n\n\nRegister here \n\n\n\nDownload the agenda here.
URL:https://www.sahpra.org.za/event/sahpras-industry-consultation-on-e-reporting-vigiflow-platform/
LOCATION:Virtual
CATEGORIES:Meeting,Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.sahpra.org.za/wp-content/uploads/2026/08/email-banner-SAHPRAs-Industry-Consultation-on-e-Reporting-VigiFlow-Platform.jpg
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