Professional Master's programme 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

1 years
MASTER - Classe per i Master (ateneo)
Controlling body
Comitato Scientifico del Master Universitario in Farmacovigilanza e Discipline regolatorie del farmaco (II Livello)
Short Master Programs (postgraduate)
Teaching and course administration
Operational unit Short Master Courses, Advanced Courses and Professional Development Courses Unit
Reference Department
Diagnostics and Public Health
Macro area
Life and Health Sciences
Disciplinary area
Medicine and Surgery

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