Sponsored: Development of next-generation COVID-19 vaccines

Sponsored: Development of next-generation COVID-19 vaccines
FREE SPONSORED WEBINAR -  Human Challenge Trials: Supporting the development of next-generation COVID-19 vaccines This webinar will navigate through the different uses of Human Challenge Trials in a regulatory strategy for a `next-generation` COVID-19 vaccine, how their data can speed up development and how they are viewed by regulators.


15 May - 14.00-15.00 BST

Human challenge trials are trials in which participants are intentionally challenged with an infectious disease organism. The model has been extensively used for a number of infectious diseases, ranging from influenza to malaria, and more recently COVID-19. These trials are often used as a proof-of-concept trial to show early efficacy of vaccines and antiviral products. In certain specific cases these trials have been used as pivotal efficacy element in FDA/EMA marketing authorisation or WHO pre-qualification.

This webinar will navigate through the different uses of Human Challenge Trials in a regulatory strategy for a `next-generation` COVID-19 vaccine, how their data can speed up development and how they are viewed by regulators..

Learning Objectives:
- Explore how to use challenge models in the development of next-generation COVID-19 vaccines and how they can fit into your regulatory strategy
- How to use data from Human Challenge Trials in discussions with global regulators
- How this data can be applied in other infectious diseases areas

Audience
This webinar will be suitable for professionals at all levels involved in development of vaccines. In addition, helpful to those who are interested in learning how Human Challenge can help the development of their product.

Speaker Bio
Bruno Speder is VP, Regulatory Affairs & Consultancy at Open Orphan plc. He holds a degree in Bio-Engineering (Ghent University, Belgium) and a degree in Health Economics (EHSAL Management School, Belgium). He has played a pivotal role in the establishment of several Human Challenge models, and has led interactions with global regulators on their use. He is currently advising a broad range of organisations (non-profits, biotechs, large pharma) on the regulatory aspects of their drug/vaccine development, including how challenge studies can be implemented in their development plans.

This webinar is sponsored by  hvivo.




Disclaimer: Whilst TOPRA is running this webinar for hvivo, this is not an endorsement of hvivo, hvivo's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

  • Members: free
  • Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.

 
When
15/05/2023 14:00 - 15:00
Where
ONLINE
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