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Module 9.9b Research and development

Objectives

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

Program : 20h theoretical courses and 10h tutorials

  • 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.