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ADAPTIVE PATHWAYS AND PATIENT ACCESS MODELS TO INNOVATIVE TREATMENTS: IS IT APPLICABLE TO THE DEVELOPMENT OF VACCINES?
Session Chair(s)
Michel Stoffel, DrMed
Vice-President, Head Europe Region, Global Regulatory Affairs
Glaxosmithkline Biologicals SA, Belgium
Viral Challenge Studies: An innovative way to speed up the development of influenza vaccines
Learning Objective : Learn how Viral challenge studies can be used as a tool to speed up vaccine development and how they can be used for an early 'go - no go' decision Learn about the Regulatory strategy required to set up this type of studies
Speaker(s)
Adaptive Pathways and Patient Access to Innovative Vaccines: A view from industry
Stephen Lockhart, MD, MA, FFPM
Sanofi-Pasteur MSD, United Kingdom
Vice President, Development
Adaptive Pathways and Patient Access Models to Innovative Vaccines: A view from the regulator
Marco Cavaleri, PHD
European Medicines Agency, Netherlands
Head of Health Threats and Vaccines Strategy
Viral Challenge Studies: An innovative way to speed up the development of influenza vaccines
Bruno Speder, MSC
SGS Life Science Services, Belgium
Head Clinical Regulatory Affairs