| 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 transvacinfo@euvaccine.eu.
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 |
Costs
This 2-day course is free of charge and includes 1 hotel night, 1 lunch and 1 dinner. Travel costs are not included.
