In 2021, AU-3S and the MHRA (as a technical partner) successfully ran a capacity strengthening programme of 5 modules covering the end-to-end PV process. These sessions were aimed at strengthening safety surveillance capacities and were recommended to anyone involved or interested in effectively monitoring the safety of medical products. The focus was on safety surveillance in general, however specific considerations for COVID-19 vaccines were raised and discussed where relevant.

The training programme consisted of five training modules which were successfully run as live webinar sessions between January – May 2021. These sessions were recorded and have now been made available for further use. Each live session saw between 100 – 250 attendees in participation, with 75% of individuals rating their experience as either very good or excellent on average across all thirteen completed sessions. A consolidated set of the training recordings, presentations, and Q&A documents has been made available for further use and distribution by all countries or organisations.

The recordings and associated learning materials for all AU-3S capacity strengthening training sessions can be accessed via the AUDA-NEPAD e-Learning portal. One does not need to create an account to access the AU-3S training page on the portal, rather simply select the option “Click here to login as guest”.

The topics covered by each of the sessions can be seen in the table below, which also includes hyperlinks to access the respective module or training recording and download any related resource documents. For any questions or comments, please feel free to reach out to the AU-3S Team by mail using AU3S@nepad.org.

The AU-3S programme aims to improve countries’ capability in signal detection in a very practical way through the AU-3S JSM Group Secretariat. For more information about the JSM Group and JSM Group Secretariat, please click here. On a fortnightly basis, a data mining run is performed based on latest available data in the DISD system. Country representatives on the secretariat take rotating turns performing all lead analyses activities for the latest data mining run performed. These activities are grouped by three categories: signal detection, signal validation, and signal prioritisation. The representative leading the data mining run cycle analysis is also responsible for facilitating the discussions in terms of both findings and potential recommendations – with both the Secretariat and AU-3S JSM Group. All other countries are involved in these discussions to promote knowledge sharing with every data mining run performed. All activities are supported by AUDA-NEPAD and the MHRA to ensure that the representatives receive sufficient guidance, can raise any questions, and can have their work reviewed for inputs and feedback as required.

This approach has provided exposure to activities that many representatives had no / little experience with, such as learning how to read and interpret disproportionality assessments such as empirical Bayesian geometric mean (EBGM).

Furthermore, the JSM Group forum encourages sharing of knowledge (perspectives, best-practices, etc.) between all members with different areas of expertise. This includes valuable technical support from reference regulatory authorities to African regulatory authorities. Country representatives can then bring new capabilities and learnings to their national safety committees and organisations.  

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 their own user access requirements and permissions. A key channel for support is through monthly super user meetings between AU-3S and the selected super users from each country, where there is a focus on experience sharing and where existing or new guidelines are provided and discussed. Overall, a ‘train the trainer’ type of approach is followed whereby country super users are trained to enable them to train other people from all organisations involved in national safety surveillance efforts.