This online self-paced course consists of four units representing the key challenges of the advanced therapy medicinal products (ATMPs) development cycle; scientific, manufacturing, reimbursement and regulatory. The new fifth unit provides information and examples on how EATRIS can support those working in ATMPs and rare diseases, through a variety of services.
Learners will be able to work through content developed by top scientists, industry experts and regulators in the field and get acquainted with the relevant literature. The course consists of a variety of different content types, including videos and interactive activities to support learners’ engagement. During the course update, accessibility has also been reviewed and improved upon to ensure all learners can access the course content.
Throughout the course learners have opportunities to provide feedback which will be used for further updates and addition of new material in the future.
A certificate is provided for all learners who complete every module of the course.
This course is free of charge and open to anyone interested in the development of ATMPs for rare diseases.
After completing this course, you will be able to:
- Define cell and gene therapy approaches and potential applications
- List the steps of the ATMP manufacturing process
- Describe the ATMP classification system and EU ATMP regulatory concepts
- Differentiate between conventional and ATMP reimbursement models
- Know where to access resources for support of ATMP development
Learn more and access the updated course here.
To support the re-use of this e-learning by other trainers many modules include an ‘Additional Materials for Trainers’ section which provides an assignment that trainers can give their students or use as the basis for development of their own assignment. Further reading is also provided so trainers can help their students expand upon the learning provided in the course in the areas they think most valuable. EATRIS welcomes expressions of interest to adapt the course to additional languages.
