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Towards the end of 2020, there was a growing acknowledgement around the need for efficient and robust safety surveillance. This developed as many African countries prepared for national COVID-19 vaccination campaigns to begin. African NRA CEOs approached AU-3S to quickly implement or enhance…
The AU-3S programme is governed by a Steering Group which is comprised of:
The CEOs of medical products National Regulatory Authorities (NRAs) from countries involved in the programme
The UK Medicines and Health products Regulatory Authority (MHRA) and the U.S. Food and Drug Administration…
Second Pan-African Stakeholder Consultation on the Development of the AIP Water Investment Scorecard
Registration for the Second Pan-African Stakeholder Consultation on the AIP Water Investment Scorecard, scheduled to take place virtually on 16 September 2021, is now open for all representatives of African government departments related to water, development and multilateral organisations, civil…
To support the use of the Vigilance Hub each country has identified a super user. The AU-3S programme has created a super user network to provide support and training in the Vigilance Hub and to enable countries to be self-sufficient in its management. In particular, countries are able to manage…
Due to relatively low levels of historical adverse event reporting in African countries, AU-3S is focused on strengthening the capacity for detecting and assessing safety signals that potentially would not be picked up in a single country’s data. The AU-3S Joint Signal Management (JSM) Group has…
It is envisioned for AfriVigilance to be a continental database that includes data on the end-to-end safety lifecycle of priority medical products in Africa. The AfriVigilance system should enable the ownership and analysis of African data in the African context. The system will pool data from…
The following updates are planned for the Med Safety App and/or Vigilance Hub:
Near the end of 2021, the data standard for the Vigilance Hub will be upgraded from ICH E2B(R2) to ICH E2B(R3).
In early 2022, an upgrade to the Vigilance Hub will enable users to attach files such as case…
