Initial situation/scientific issue

The main objective of this joint action programme is to improve the availability of medicines by providing a framework to address the following two challenges:

1. The increased workload due to the COVID-19 pandemic.

2. The rapid development of science and the integration of innovative technologies into regulatory processes at all levels, from scientific advice and clinical trials to marketing authorisation applications, for which sufficient expertise and frameworks are currently not available.

Project description/methodology

Regulatory experts in drug regulatory authorities are increasingly faced with the challenge of increasing workloads and rapidly advancing scientific developments for which no expertise or framework is available. In addition, the lack of division of labour, cooperation and collaboration prevents efficient use of the resources already available. To address these issues, the planned action of 31 partners aims to fill the identified gaps in required capacities, competences and frameworks.

First, the action aims to develop training courses in the areas of most urgent need. In order to identify the most urgent needs, a mapping of the content of the EU-NTC (The European Union Network Training Centre) and other training materials is carried out. In order to achieve the best results, best practices for the training of assessors will be developed. Furthermore, an on-the-job training programme will be established to support learning and coaching activities.

The action programme will also identify recommendations for optimising processes in the EMRN (European Medicines Regulatory Network) and avoiding overlaps.

Outcomes