Joint HMA/EMA initiative: EU Network Training Centre
Introduction and Overview
The EU Network Training Centre (EU NTC) is a new initiative on training endorsed by the HMA (the HMA meeting in Athens in February 2014) and during the EMA Management Board meeting in March 2014. The EU NTC aims:
• to improve the quality, consistency and efficiency of the work of the European Medicines Regulatory Network (EMRN);
• to promote harmonised operation of the regulatory framework and guidelines throughout the EMRN;
• to foster science based, pragmatic and consistent assessment, inspection, pharmacovigilance, decision making and carrying out of regulatory measures;
• to provide continuous professional development for staff of national regulatory agencies and EMA and, possibly, others involved in development of medicines regulation
Christa Wirthumer-Hoche (HMA) and Zaide Frias (EMA) were nominated as co-chairs for this initiative. The mission of the EU NTC is to ensure that good scientific and regulatory practices are spread across the network along with harmonised training standards, through the provision of high quality and relevant training materials identified and shared through by the EU NTC platform.
In order to achieve this mission, the EU NTC a joint initiative between the HMA and EMA, seeks to establish an online European training platform to have a single point of access for all scientific and regulatory trainings for the EMRN.
During the HMA meeting in Toledo in May 2014, the HMA endorsed the EU NTC mandate including its governance. The mandate includes:
- to develop a training strategy for continuous professional development addressing needs of EMRN, covering human and veterinary medicinal products;
- to provide a coordinated approach to training: definition of competence and knowledge requirements, development of training curricula and assessment methodology, quality assurance of training provided.