Masters (level 2) in Pharmacovigilance and Drug Regulations


Course objectives
Graduates of this Masters programme will:
- understand the national and international contexts in which pharmacovigilance and pharmaceutical laws and regulations operate.
- know the regulations and methods of premarketing trials.
- know the national and European legislation on pharmacovigilance.
- understand and be able to appropriately apply different epidemiological methods for drug surveillance.
- know and be able to apply post-marketing drug management procedures.
- understand the main mechanisms of harm from drugs, the epidemiology of adverse reactions and the risk factors for adverse reactions.
- know the role and responsibilities of pharmacovigilance supervisors and managers in the industry and in the national health system.
- understand and be able to manage the signs and symptoms of adverse drug reactions.
- know how to use adverse drug reaction databases.
- know how to identify reliable sources of information on drugs.
- know how to manage “drug crises”.
- know the regulations on medical devices.
- know the regulations and methods for controlling environmental pollution by drugs.

Possible careers or places of work
- pharmacovigilance manager in a pharmaceutical factory, local health establishment, hospital or scientific institute for hospitalisation and treatment
- regulatory personnel in the pharmaceutical industry
- Italian Medicines Agency
- European or non-European regulatory agencies
- WHO Uppsala Monitoring Centre.

Course details

Short Master Programs (postgraduate)
1 years
Degree class
MASTER - Classe per i Master (ateneo)
Supervisory body
Comitato Scientifico del Master Universitario in Farmacovigilanza e Discipline regolatorie del farmaco (II Livello)
Teaching and course administration
Operational unit
Main Department
Diagnostics and Public Health
Macro area
Life and Health Sciences
Subject area
Medicine and Surgery