Capitalising on EU Network Training Centre for capacity and - - PowerPoint PPT Presentation

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

• pportunities

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How does the EU Network Training Centre work?

Christa Wirthumer- Hoche (HMA)

Co-chairs

Zaide Frias

(EMA) Network of EMA and NCA local ambassadors supporting the coordination and communication of EU NTC activities

Training Champions

assists in the daily running

• f the centre

EU NTC Support team

made up of representatives from HMA, NCAs and EMA.

Training Steering Group Governance

Vision: Building Blocks of EU NTC

Implement a blended learning strategy that supports retention, and transfers knowledge from training to business results. Address the diverse needs of the audience: staff members from all European NCAs and the EMA. Develop a competence matrix, specifying the necessary levels of competence/knowledge per role, based on best practices from the Network. Harmonise standards of knowledge and training, and facilitate collaboration across the Network. Offer a training catalogue that centralizes all learning offerings shared across the NCAs and EMA. Continuously evaluate whether trainings are reaching the desired

• bjectives, and look for ways to improve

the offering. 3

The journey from January 2015 to today: laying the foundation

• 15 courses approved for reimbursement

by the EU NTC

• 280+ participants reimbursed for

attending

Reimbursing training participation

• First training catalogue for all network staff
• 150+ training events
• 22 agencies contributed by opening up their

training

Building EU NTC training catalogue

• Advertising the EU NTC catalogue +

information/documents and forms

• 2250 unique visitors since launch in Feb ‘15

Launching EU NTC interim platform

• A resource-effective way of opening

local training to the network

• 46 webinars supported

Encouraging and supporting webinars

A new milestone for the EU NTC and the network

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To continue fulfilling its mission in a resource-effective and sustainable way, the EU NTC has launched

Learning Management System (LMS)

EU NTC Interim platform New EU NTC LMS

Competency matrix and curriculum development

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• 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

Scientific Advice

Pharmaco vigilance

Clinical Trials

• Easily find, register and track courses through one

user-friendly central platform

• Ability to offer feedback and recommend courses
• Instant access to qualitative training from across the

Network, including online training

• Knowledge spreading: easier for agencies to open up

courses or share materials with the network

• Scientific curricula offered for the different areas of

expertise for targeted career development

Benefits of the Learning Management System

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Inspections

Marketing authorisation assessment

Veterinary

Paediatrics

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

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More information/Questions networktraining@ema.europa.eu