Farmacovigilanza storia, quadro regolatorio e realta’ italiana - Storia della farmacovigilanza (2017/2018)

Course code
Name of lecturer
Roberto Leone
Number of ECTS credits allocated
Academic sector
Language of instruction
not yet allocated

To show the organization of the course that includes this module, follow this link * Course organization

Learning outcomes

Know the history of pharmacovigilance


From Homer to Hippocrates. The first pharmacovigilance activity, promoted by The Lancet, following the death of Hannah Greener. The Federal Food Drug Cosmetic Act of 1938 and sulphanilamide poisoning. Gastrointestinal haemorrhages from aspirin. The tragedy of thalidomide milestone for spontaneous reporting of adverse drug reactions. The birth of the WHO Programme for International Drug Monitoring. The steps of the evolution of Italian rules in pharmacovigilance.

Reference books
Author Title Publisher Year ISBN Note
Caputi, De Ponti, Pagliaro Reazioni avverse a farmaci Cortina Editore 2009 978-88-6030-278-6

Assessment methods and criteria

Examination is not required but only participation in the lesson