African Union Smart Safety Surveillance (AU-3S) Joint Signal Management (JSM) Group In-Person Meeting
To continue facilitating cross-country signal management on combined safety data for medical products, with a specific focus on COVID-19 vaccines, the African Union Smart Safety Surveillance (AU-3S) programme will hold the second in-person Joint Signal Management (JSM) meeting from the 27th – the 28th of March 2023 in Accra, Ghana.
The JSM Group meeting will have in attendance its members comprising of representatives from the AU-3S programme member countries’ (Ethiopia, Ghana, Kenya, Nigeria and South Africa) National Regulatory Authorities (NRAs), Expanded Programme on Immunization (EPI), national safety advisory committees, and few independent experts; representatives from the AU-3S programme’s technical partner - the UK Medicines and Healthcare Products Regulatory Authority (MHRA), and representatives from the Bill and Melinda Gates Foundation (BMGF), as well as the AUDA-NEPAD (AU-3S team).
The meeting is preceded by refresher training sessions on causality assessment, signal management and signal validation, as well as several virtual engagements which have ensured continued implementation of joint safety surveillance activities by the AU-3S member countries. The training activities form a part of the programme’s continuous capacity-building efforts for the participating countries.
Against this backdrop, the upcoming JSM Group meeting will ensure an informed safety profile of medicines (currently COVID-19 vaccines) through sound scientific recommendations while providing continual capacity strengthening for the members to be well equipped with the evolving approaches and knowledge on signal management as well as the appraisal of safety data to inform policy decisions on the safety of priority medical products in Africa. The meeting objectives are as follows:
- Asses aggregate safety reports in the Data Integration and Signal Detection (DISD) system for the purpose of providing recommendation(s) for in-country consideration and stakeholder information.
- Review and provide input to the JSM Scientific publication.
- Capacity building and discussion on the consideration of Brighton’s list of adverse events of special interest (AESIs), definitions and companion guidelines to support signal validation.
This meeting contributes to the primary and intermediate outcomes of the AU-3S programme. Additionally, this engagement will facilitate the process of obtaining recommendations on specific AESIs as well as identified items of interest.
To date, the AU-3S programme continues to work closely with the participating countries to provide strategic and technical support with the aim of improving health systems and safety surveillance capacity across Africa. While significant headway in supporting the AU-3S member countries has been made, the programme endeavors to accelerate the plans for regional expansion to pivot towards a continental platform as well as product scope expansion through the addition of more priority health products to the programme focus.