EU Network Training Centre (EU-NTC) - former OTSG

Introduction/Overview/Mandate

Joint HMA/EMA initiative: EU Network Training Centre

Introduction and Overview

The 'EU Network Training Centre' (EU NTC) is an initiative set up by the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), in collaboration with the EU medicines agencies regulatory network (EMRN), further to discussions at the HMA meeting in Athens on 18-19 February 2014.

The mission / aim of the EU NTC is to ensure that good scientific and regulatory practice is spread accross the EU medicines agencies regulatory network along with harmonised training standards, through the provision of high quality and relevant training shared through a European central platform (the EU NTC Learning Management System).

The EU NTC has at its core the following key objectives:

  • To improve the quality, consistancy and efficiency of the work of the European medicines regulatory network;
  • To promote harmonised operation of the regulatory framework and guidelines throughout the European regulatory network;
  • To foster science based, pragmatic and consistant assessment, inspection, pharmacovilance and decision making;
  • To provide continuous professional development for staff of national regulatory agencies and possibly other stakeholders involved in development of regulation of medicines.

EU NTC Activities: The EU NTC initiative, through its governance structure, works to:

  • Develop a training strategy (for continuous professional development) that addresses the needs of the European medicines agencies network;
  • Develop / provide a coordinated approach to training in key focus areas within the European medicines agencies network covering human and veterinary medicinal products;
  • Work with expert bodies for key topic areas to drive training priorities and to track the development and delivery of training;
  • Manage a catalogue of training courses made available through an online common centralised digital platform (Learning management System (LMS);
  • Co-ordinate the network of Training Champions and Local Administrators from across NCAs and the departments of EMA to promote the EU NTC and its training activities.

The EU NTC has as its core, the following pivotal groups:

(i) Training Steering Group (TrSG) which overseas the running of the EU NTC at a stratigic level. The TrSG is Co-chaired by an NCA and an EMA representative and is composed of members appointed by the HMA and EMA.

(ii) Training Champions, appointed by EMA and by each NCA, who support the EU NTC at a tactical level and act as a point of contact for the EU NTC within their NCAs/EMA division.

(iii) Local Administrators, appointed at the level of the NCA, who are responsible for managing agency-level training activities in the EU NTC LMS at an operational level.

(iv) Curriculum specific Steering Groups, set up in specifc topic areas, to assist the EU NTC in identifying and prioritising training needs and working with course experts in the design, development and delivery of training.

(v) EU NTC Secretariat, provided by the EMA.

Members and Representatives

Members and Representatives

Training Steering Group Members (2018): The Co-chairs of the EU NTC Training Steering Group are Christa Wirthumer-Hoche (HMA) and Fergus Sweeney (EMA). Current members of the TrSG are drawn from AT, CZ-h, DE-h, EE, IE, FR-h, NL, UK-h and EMA.

As the names of the appointed EMA and NCA Training Champions and Local Administrators are subject to change on a regular basis, the updated list of these persons can be requested from the EU NTC Secretariat at: networktraining@ema.europa.eu. These lists will also be included in the future on an EU NTC specific webpage on the Eudraportal (accessible to NCAs) - currently under revision.

Contact

Contact Point

e.mail networktraining@ema.europa.eu

Key documents list

Key documents

EU NTC Structure | pdf

In the following video, Christa Wirthumer-Hoche (HMA) and Fergus Sweeney (EMA) Co-chairs of the EU NTC initiative, explain what the EU NTC does:

Short version (2 min) | video

Longer version (5 min) | video