Colleagues in the European medicines regulatory network can access the modules through the EU Network Training Centre Learning Management System, EU NTC LMS (please see instructions how to access it at the bottom of the article). Each module consists of a series of different chapters.

1.    Introduction to Real World Evidence – 3 chapters

·       This module aims to provide an introduction to the roles of real-world evidence in regulatory practice and studies that can be conducted in this context.

·       Topics covered include: roles of RWE in regulatory practice, concepts and definition used in regulatory practice, objectives of studies in regulatory practice.

2.    Real-World Data sources – 5 chapters

·       This module provides an overview of the different data sources that can be used to generate real world evidence, focusing on aspects such as data access, data heterogeneity and data quality.

·       Topics covered include: landscape of data sources, data level, access and sharing, dealing with heterogeneity of data sources, data quality, and other aspects relevant to specific data sources.

Overseen by the Methodology Working Party, the Big Data curricula will include trainings in the domains of biostatistics, pharmacoepidemiology/real world evidence and data science. Further modules in the Pharmacoepidemiology and RWE curriculum will be published over the next two years.  Work is also ongoing on the development of a Data Science curriculum, with the first modules in this curriculum expected to be released in January 2024.

The HMA/EMA vision on Big Data aims to strengthen the regulatory system by efficiently integrating data analysis into decision-making processes. The Big Data training curricula plays an important role in supporting the development of an expert workforce in the EU network, equipped to advise on and interpret big data. The curricula delivery is part of the joint HMA/EMA Big Data Steering Group Workplan 2023 – 2025 and European medicines agencies network strategy to 2025.

REGISTERING YOUR ACCOUNT IN THE EU NTC LMS / PASSWORD RESET: 

The LMS can be accessed by all network staff with a personal LMS account. You only need to register your account once in the LMS.

Once your account has been approved, you can register for instructor-led courses or start online training modules (videos, e-learning modules) in the EU NTC catalogue directly from the platform. 

If you do not have your personal LMS account yet, please do the following:

·       To get your LMS account: Follow this link to the LMS login page for NCA colleagues and click on ‘New user?’ to access the digital registration form. When you click ‘Submit’, the form will be sent to your agency’s EU NTC local administrator for approval. Once your account has been approved you will receive an email with a link to activate your account and set up your password. Check your SPAM folder if you don’t receive the email in your inbox.

·       If you forget the password for your LMS account: Please use Forgot password? link on the Sign On page (SuccessFactors Learning → Login (plateau.com)) and enter your ID or email address. Once you click continue, you will receive an email with a link to reset your password.