The main objective of this regulatory training course at Swissmedic is to strengthen the capacity of the participating NRAs through experience and knowledge exchange in applying up-to-date methods and procedures for the day-to-day processes in Quality Management System (QMS), Registration and Marketing Authorization (MA) and Vigilance (PVL) in accordance with the WHO and other international standards and good practices.
For this purpose, the participants will engage in a peer learning experience and will be able to use the practical application of methods and procedures for the above-mentioned regulatory functions. More specifically this regulatory training course will lead to an increased capacity to interpret and apply the WHO and other international standards in their day-to-day activities in developing and implementing the good practices for the quality management system, marketing authorization and vigilance functions in their own NRAs. Swissmedic has agreed to host this regulatory training course within its development co-operation framework and cooperation with WHO to improve and accelerate access to health interventions and therapeutic products in resource-constrained countries by strengthening regulatory systems.
