Sponsored: how regulators view Human Challenge Trial results

Sponsored: how regulators view Human Challenge Trial results
FREE SPONSORED WEBINAR - From breakthrough designation to pivotal efficacy data: how are global regulators looking at Human Challenge Trial results?

21 June 2022
Time: 15:00 - 16.00 BST (GMT+1) 

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 different uses of Human Challenge Trials in a regulatory strategy, how their data can speed up development and how they are viewed by regulators. A number of case studies will illustrate how challenge studies have been used in the framework of regulatory discussions with FDA and EMA.

Learning Objectives
- Explore how to use challenge models in the development of vaccines & antivirals and how they can fit into your regulatory strategy
- Learn how to use data from Human Challenge Trials in discussions with global regulators

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 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.

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.


21/06/2022 15:00 - 16:00
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