3rd ENOVA Adjuvant Workshop 23-24 September 2019 Belgrade, Serbia
The Workshop will run over two full days. Monday, 23 September will be dedicated to ENOVA Working Group Sessions and Management Committee Meeting. Tuesday, 24 September will address Regulatory Considerations in the development of adjuvanted vaccines. Below you will find an outline of the agenda.
- All ENOVA members are invited to attend and can register by answering the doodle poll before 15 July 2019 (first come first serve): https://doodle.com/poll/g6q6sdvzx4chcg6b (eCOST invitation will follow in a second step).
- Remaining places will be allocated to interested scientists and Early Career Investigators. They must fill in the attached application form and submit it by 15 July 2019.
- Introduction to adjuvant/vaccine (GLP/GMP) discovery/development pipeline and registration dossier (different modules)
- Adjuvants and the regulatory perspective: which adjuvants have been licensed and how opinion changed towards adjuvants after certain AEs
- Regulatory affairs from a vaccine/adjuvant developer point of view
- CMC (chemistry manufacturing and control) quality (Regulatory and developer’s perspective)
- Toxicology (Regulatory and developer’s perspective)
- Clinical (Human and veterinary trials
- How to get Information from authorities
- Case stories
- Q&A panel discussion