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Regulatory aspects of vaccine development
M14
Course Goals
This two-day interactive training workshop on vaccine development will introduce participants to planning a regulatory strategy for vaccines with emphasis on the early phases of development. Day 1 will focus on prophylactic vaccines while day 2 will focus on cancer vaccines. The workshop will be designed based on the current bottlenecks and upcoming innovative approaches while planning a regulatory strategy.
Timeline
Application Deadline:
15 December 2021
Course Dates:
21-22 March, 2022
Organiser
The European Infrastructure for Translational Medicine (EATRIS)
Amsterdam, The Netherlands
Participant Nr.: 20
Contact
Lauranne Duquenne lauranne.duquenne@eatris.eu
Course content
The course is designed for professionals working on vaccine development who are in need of an introduction to the regulatory issues associated with the field. Day 1 will focus on prophylactic vaccines, including lectures and case studies on how to navigate the regulatory maze and how to plan a regulatory strategy, preclinical and Phase I-II of vaccine development, how to prepare a dossier for Medicine Agencies, CMC development. Day 2 will focus on cancer vaccines, with an introduction to the scientific part to understand the regulatory part better.”
Learning Outcomes
Learn how to plan a regulatory strategy from the early phases of development and prepare a well-organised dossier in a changing environment.
Who should apply
Vaccine developers and European researchers from industry and academia.
Minimal requirements
NA
Accommodation
Accommodation: the course will be held in Amsterdam, The Netherlands (exact location to be confirmed). 1 hotel night, 2 lunches and 1 dinner included. Travel costs are not included.
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