Regulatory aspects of vaccine development

Date & Time June 11-12th, 2020
Address Hotel Element
A.J. Ernststraat 577,
1082 LD Amsterdam,
The Netherlands

Location Hotel Element

Workshop description

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.


Target audience

Vaccine developers and European researchers from industry and academia


Selection procedure

Applicants must use the application form available at the TRANSVAC2 website and submit it electronically in PDF format by e-mail to

The call will open on February 15th, 2020 and close again on March 15th, 2020. Selected candidates will be notified by April 1st 2020.

Timelines – Launch of Call DDL for submission Decision by
Feb 15th 2020 March 15th 2020 April 1st 2020


Draft agenda

June 11th 2020 Regulatory  strategy when developing a classic vaccine Speaker
9.00 -9.30 Welcome  and introduction
9.30-10.30 How to navigate the regulatory maze and plan a regulatory strategy Jiri Deml
10.30 – 10.45 Coffee break
10.45 – 12.00 CMC vaccine development Leo van der Pol
12.00- 12.30 Quality by design Leo van der Pol
12.30 -13.30 Lunch
13:30 – 14:00 Animal testing Jiri Deml
14:00 – 15:00 Clinical phases (phase I &II) Pauline Verdijk
15.00 – 15.15 Coffee break
15.15 -16.00 How to prepare dossier for MA Jiri Deml
16.00-17.30 Exercise 1 Leo van der Pol


June 12th 2020 Cancer and DNA vaccines Speaker
9.00 – 10.30 Cancer vaccine – regulatory part Maria Cristina Galli
10.30-10.45 Coffee break
10.45-11.30 Cancer vaccine- scientific part: Achievements, Needs and challenges Lucia Gabriele
11.30-12.00 DNA vaccines – lessons on approach for pandemic flu or Ebola Giovanni Migliaccio
12.00- 13.00 Lunch
13.00 – 15.30 Group exercise 2  and discussion Maria Cristina Galli
15.30 – 15.45 Wrap up and farewell


This 2-day course is free of charge and includes 1 hotel night, 1 lunch and 1 dinner. Travel costs are not included.

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