WHO IS THE COURSE FOR?
This course is for professionals working on vaccine development who need an introduction to the (EU) regulatory requirements associated with the field.
HOW DOES THE COURSE WORK?
This is a free, self-paced online course, however registration for our e-learning platform is required. The course consists of a variety of different content types, including text, images, videos, and quizzes. It has an average study time of 8-10 hours of interactive learning content. Upon successful completion of the course you will receive a certificate.
WHAT WILL YOU LEARN?
- How to navigate the regulatory maze
- Chemistry, Manufacture and Control (CMC)
- Regulatory landscape for preclinical testing
- Clinical Vaccine Development
- Cancer vaccines and ATMPs
- Scientific basis of Cancer vaccines
- COVID-19 vaccines development
By the end of the course, you will be able to:
- Discuss the regulatory landscape for preclinical and clinical testing, including relevant animal models, clinical trial design, efficacy endpoints and clinical trial application
- Describe the scientific basis and regulatory landscape for cancer vaccines and ATMPs with highlights on CMC, non-clinical and clinical aspects for cancer vaccines
ACCESS THE COURSE
NEED HELP?
If you need any help accessing the course, please email training@eatris.eu.
FUNDING
This online course was developed within the Horizon 2020 funded project TANSVAC2. TRANSVAC2 was a 5 year infrastructure project, supported by Horizon 2020, that aimed to accelerate the development of effective vaccines urgently needed to address European and global health challenges.
TRANSVAC2 supported innovation for both prophylactic and therapeutic vaccine development by providing high-quality technical services across four different service platforms: Technology (for process development and GMP production), Immunocorrelates & Systems Biology, Animal models, and support for Clinical Trials. TRANSVAC also offered training courses to provide fundamental and advanced knowledge on a wide-range of vaccine development-related topics.
