|Date & Time||June 11-12th, 2020|
A.J. Ernststraat 577,
1082 LD Amsterdam,
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.
Vaccine developers and European researchers from industry and academia
Applicants must use the application form available at the TRANSVAC2 website and submit it electronically in PDF format by e-mail to email@example.com.
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|
|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|
|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|
|10.45-11.30||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|
|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.