We have launched a new online course on regulatory aspects of vaccine development. The course is based on materials developed as part of the TRANSVAC project that was supported by Horizon 2020.
The course is designed for professionals working on vaccine development who need an introduction to the (EU) regulatory requirements associated with the field. The course covers mainly prophylactic vaccines including CMC, preclinical and Phase I-II of vaccine development, and touches on therapeutic and cancer vaccines as well, both from the scientific and regulatory point of view.
The self-paced course features both prophylactic and cancer vaccines from the scientific and regulatory points of view and is divided into 7 learning units:
- How to navigate the regulatory maze
- Chemistry, Manufacture and Control
- Regulatory landscape for preclinical testing
- Clinical Vaccine Development
- Cancer vaccines and ATMPs
- Scientific basis of Cancer vaccines
- COVID-19 vaccines development
An overview of the course can be found here
We wish to thank all the TRANSVAC2 project partners who contributed to the course materials: EATRIS, Istituto Superiore di Sanità (ISS), Intravacc and Asphalion
The pilot course is now open for EATRIS members!
Browse the curriculum below or download here.
