Capitalising on EU Network Training Centre for capacity and capability building in the EU network HCPWP workshop on developing a framework for collaboration between EMA and Academia - 15 June 2016 Presented by: Zaide Frias, Head of Human Medicines R&D Support Division
What is the EU Network Training Centre? The EU NTC is a joint HMA & EMA initiative with the mission to ensure the exchange of good scientific and regulatory practices across the EU regulatory network , by harmonising training standards and offering high quality and relevant training opportunities 1
How does the EU Network Training Centre work? Co-chairs Training Steering Group EU NTC Support team Governance Christa Wirthumer- Zaide Frias Hoche (HMA) (EMA) Training Champions made up of representatives from assists in the daily running HMA, NCAs and EMA. of the centre Network of EMA and NCA local ambassadors supporting the coordination and communication of EU NTC activities
Vision: Building Blocks of EU NTC Develop a competence matrix , specifying the necessary levels of Address the diverse needs of the audience : competence/knowledge per role, based on staff members from all European NCAs best practices from the Network. and the EMA . Implement a blended learning Offer a training catalogue that strategy that supports retention, and centralizes all learning offerings transfers knowledge from training to shared across the NCAs and EMA. business results. Continuously evaluate whether Harmonise standards of knowledge and trainings are reaching the desired training, and facilitate collaboration across the objectives, and look for ways to improve Network. the offering. 3
The journey from January 2015 to today: laying the foundation Building EU NTC training catalogue Encouraging and supporting webinars First training catalogue for all network staff A resource-effective way of opening 150+ training events local training to the network 22 agencies contributed by opening up their 46 webinars supported training Reimbursing training participation Launching EU NTC interim platform 15 courses approved for reimbursement Advertising the EU NTC catalogue + by the EU NTC information/documents and forms 280+ participants reimbursed for 2250 unique visitors since launch in F eb ‘15 attending
A new milestone for the EU NTC and the network To continue fulfilling its mission in a resource-effective and sustainable way, the EU NTC has launched Learning Management System (LMS) New EU NTC LMS EU NTC Interim platform 5
Competency matrix and curriculum development FAMHP (BE) led the development of competency matrices and curricula in the field of Clinical Trials, where the • methodology was tested and agreed, with the support of the EU NTC. Next areas for competency and curricula development: Quality, Regulatory Affairs, Paediatrics, Veterinary topics, • Pharmacovigilance and ATMPs 6
Benefits of the Learning Management System Easily find, register and track courses through one • user-friendly central platform Scientific Paediatrics Advice Ability to offer feedback and recommend courses • Instant access to qualitative training from across the • Inspections Network, including online training Marketing Clinical authorisation Trials Knowledge spreading: easier for agencies to open up • assessment courses or share materials with the network Veterinary Pharmaco Scientific curricula offered for the different areas of • vigilance expertise for targeted career development 7
EU NTC and Academia - Possibilities for future collaboration Provide access to academia to some of the training events organised. i.e. webinars Involvement of academia to the curricula development in some scientific areas Involvement of academia for the delivery of training programmes 8
More information/Questions networktraining@ema.europa.eu 9
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