Sponsored: The worlds first Covid-19 Human Challenge Trial

Sponsored: The worlds first Covid-19 Human Challenge Trial
FREE SPONSORED WEBINAR -  The worlds first Covid-19 Human Challenge Trial: The Regulatory challenges. This webinar will navigate through the regulatory strategy that resulted in the approval and execution the world’s first Covid-19 human challenge trial, in which healthy volunteers where deliberately infected with SARS-CoV-2. You will be taken step-by-step through the regulatory approach, from the manufacturing of the human challenge agent, over the Scientific Advice meetings with Regulators, to the Clinical Trial Approval and the discussions with the Ethics Committee.


16 November - 15.00-16.00 GMT

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. These trials are often used as a proof-of-concept trial to show early efficacy of vaccines and antiviral products.

This webinar will navigate through the regulatory strategy that resulted in the approval and execution the world’s first Covid-19 human challenge trial, in which healthy volunteers where deliberately infected with SARS-CoV-2. You will be taken step-by-step through the regulatory approach, from the manufacturing of the human challenge agent, over the Scientific Advice meetings with Regulators, to the Clinical Trial Approval and the discussions with the Ethics Committee.

We will also highlight the utility of the SARS-CoV-2 Human Challenge model in the development of future Covid-19 vaccines and antiviral products.

Learning Objectives
- Explore how the SARS-CoV-2 Human Challenge model was established
- Learn how to use this challenge model in the development of Covid-19 vaccines and antivirals and how it can fit into your regulatory strategy

Audience
This webinar will be suitable for professionals at all levels involved in development of vaccines and antivirals. In addition, helpful to those who are interested in learning how a SARS-CoV-2 Human Challenge was established and how it can help the development of their product

Speaker Bio
Bruno Speder is VP, Regulatory Affairs & Consultancy at Open Orphan. 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
16/11/2021 15:00 - 16:00
Where
ONLINE
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