In partnership with the WHO, Swissmedic devised a training course for regulatory authorities in low- and middle-income countries1. Such courses are part of the WHO’s programme to improve its member states’ regulatory systems. The aim of project component III is to develop the capacities at these National Regulatory Authorities (NRAs) so that they can function more effectively. The regulatory training is structured as a “peer learning” event, i.e. learning goals are achieved primarily through interaction with other specialists and colleagues. In this four-day workshop, participants gain a better understanding and acquire new skills for developing and implementing their knowledge of regulatory processes and approaches. The presentations and discussions enable the participants to better understand the processes, approaches and strengths of both Swissmedic and visiting NRAs as well as the challenges facing them.
The workshop is partly conducted in three parallel modules:
- Marketing authorisation
- Market surveillance/pharmacovigilance
- Quality management system/GMP inspections
Swissmedic holds this regulatory training in partnership with the WHO twice a year. Eight authorities are invited to send three experts to each course. Six of these authorities are invited by the WHO, two by Swissmedic itself. To ensure the long-term sustainability of the project, the foreign authorities are required to submit an action plan to the WHO, setting out how they intend to implement the knowledge acquired by participants.
For dates and further information please contact: