Regulatory aspects of vaccine development


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.


Application Deadline:
15 December 2021

Course Dates:
17-18 May, 2022


The European Infrastructure for Translational Medicine (EATRIS)

Amsterdam, The Netherlands

Participant Nr.: 20


Lauranne Duquenne

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



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.





How to apply>>

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