European Medicines Agency (EMA), as part of the IPA programme, held a training on 2–3 October focused on the assessment of the safety and efficacy of medicines, simulating real evaluation processes of the Committee for Medicinal Products for Human Use (CHMP).
Assessors from national competent authorities in candidate countries and potential candidates for the EU membership took part in this training; they represented the following countries:
- Albania
- Bosnia and Herzegovina
- Kosovo
- Montenegro
- North Macedonia
- Serbia
- Ukraine
The event was hosted by the Institute for Medicines and Medical Devices of Montenegro. This was also the first time that a candidate country organised an annual training for assessors, which is a significant step towards strengthening cooperation with the European regulatory network.
The objective of this training was to provide support to candidate countries and potential candidate countries for the EU membership in the process of harmonisation with Acquis Communautaire in the field of regulations of medicines, with a particular focus on safety and efficacy of medicines assessment.
The Institute for Medicines and Medical Devices will continue to enhance its capacities in line with the European standards, with a clear objective of providing quality, safe and effective medicines to citizens of Montenegro and of contributing to the single European market and stronger international cooperation.
