UE 9-9b : Research and Development

  • Objectives 
Clinical trials, regulatory and legal aspects. Good practices. Intellectual property. Development and production strategies.
 

  • Program and Content of the Module
Theoretical courses : 20 h
  •  Preclinical studies
  • Statistics for clinical trials
  • Clinical development of vaccines, clinical development of therapeutic antibodies
  • Biosafety of vaccines (search for biological contaminants)
  • Regulatory aspects of vaccines
  • Intellectual property and patents
  • Pharmacovigilance
  • Choice criteria for introduction of a vaccine in the vaccination agenda
     
Tutorials : 10 h