A new generation of Genetically Modified (GM) vaccines: How to overcome the hurdles from bench to practice?

Flanders Vaccine’s Symposium: 


A new generation of Genetically Modified (GM) vaccines: How to overcome the hurdles from bench to practice?

March 19, 2019 

FOD-WASO – Ernest Blerotstraat 1, 1070 Brussels
(located on the opposite of Pullman Hotel or exit ‘Hortaplein’ of the railway station Brussels South/Midi)


Deadline: March 5, 2019

To overcome the limitations of traditional vaccines, the development and use of novel types of vaccines, especially those based on GM technology, are being considered more frequently.

Although GM vaccines are endowed with unique and beneficial qualities, major regulatory -, safety – and other aspects need clarification.

  • What are the Belgian regulatory guidelines for the development of these novel types of vaccines? Is there a difference with other national regulatory frameworks in European countries?
  • What are the challenges encountered in the pre-clinical and clinical field?
  • How can we guarantee the safety and effectiveness of GM vaccines?
  • Is there an environmental risk associated with the use of GM vaccines?

Join this symposium and learn more about these current and interesting topics. A panel of experts will be happy to answer your questions and fuel the discussion.


12:15-13:00: Registration and Welcome lunch (sponsored by PhaRA)

13:00-13:10: Introduction by Prof. Corinne Vandermeulen, KU Leuven, board member of Flanders Vaccine

13:10-13:30: Belgian regulatory framework and guidance on the use of genetically modified vaccines in a clinical setting
by Katia Pauwels, Biosafety & Biotechnology unit, Sciensano

                 13:30-13:40: Clinical trials with GMO-containing vaccines in Europe: status and regulatory framework
               by Florence Kauffmann, FAMHP graduate

13:40-14:00: European regulatory aspect of GM Vaccines
by Prof. Dr. Pieter Neels, Vaccine Advice, International Alliance for Biological Standardisation (IABS)

14:00-14:15: Yellow fever – PLLAV technology: concept, mechanism-of-action and applications
by Dr. Kai Dallmeier, Research Expert Virology & Chemotherapy, Group Leader Molecular Vaccinology and Vaccine Discovery, KU Leuven

14:15-14:30:  PLLAV technology: towards market authorisation in the veterinary field
by Dr. Melody Janssen, Program Manager Vaccines, Virovet

14:30-15:00: COFFEE BREAK

15:00-15:20: A company perspective in clinical trials setting with GMO vaccines
by Dr. Myra Widjojoatmodjo, Global Regulatory Affairs, Janssen Vaccines & Prevention

15:20-15:40: Human challenge trials and GMO’s: ‘a challenging combination’
by Bruno Speder, Head Clinical Regulatory Affairs and Consultancy, SGS

15:40-16:20: Interactive Panel Discussion (all speakers and Stephanie Mali, Center of Excellence for Vaccines, FAMHP)

16:20-16:30: Closing of the day – by Prof. Pierre Van Damme, UAntwerp, vice-chairman of the board of Flanders Vaccine

16:30-17:30: Networking reception


  • Isabel Leroux-Roels (session before the coffee break)
  • Geert Leroux-Roels (session after the coffee break)

Interactive Panel Discussion:

Questions for the expert panel can be submitted to info@flandersvaccine.be until March 5, 2019. There will also be the possibility to ask your questions on the spot.






We encourage you to take advantage of this unique opportunity to participate as a sponsor and to enlarge the visibility of your company within this network of stakeholders involved in GM Vaccine development, production, regulation or clinical studies.

We can offer you a sponsor package for lunch (SOLD OUT), coffee break or the closing reception at very affordable prices. Prices are excl. VAT.










For more information, please contact:

Flanders Vaccine vzw
Fran Van Heuverswyn

T +32 11 28 69 04 | M +32 475 42 90 91

This symposium is organised in collaboration with the Federal Agency of Medicines and Health Products (FAMHP).   

Cancellation Policy:
Notifications received upon 2 weeks before the start of the event, get refunded for 100%. Cancellation requests received less than 2 weeks before the start of the event won’t be refunded. No-shows on the day of the event will not be refunded and are requested to pay the full fee. Replacement by a colleague is always allowed.