Presentations : Bridging studies – why and how? Peter Dull, Bill & Melinda Gates Foundation. Criteria and requirement for the licensing of new vaccines with special emphasis on COVID-19 the view of EMA. Marco Cavaleri, Head of Office Biological Health Threats and Vaccine Strategy, European Medicines Agency.
There will be two main presentations as follows: The Immunological benefits of mRNA and potential applications - Presenter: Barney Graham, previously with the National Institute of Health, USA. Regulatory approaches: Issues and challenges, and questions to be asked by regulators - Presenter: Philip Krause, Food & Drug Administration, USA.