Programme location: VERONA
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.
Modules and other information
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.
Available places: Min. 10 - Max. 40
Admission test
AMMISSIONE AL Master in Farmacovigilanza e Discipline regolatorie del farmaco
- Application deadline
- November 15, 2018
- Documents and call for applications
-
Bando e allegati
Graduatoria
- Duration
- 1 year
- Entry type
- admission test, limited-entry degree
- Frequency
- Frequenza obbligatoria: 75%
- Language
-
italian - Fees
- Quota iscrizione al Master: € 2.700,00 + € 16,00 di marca da bollo
€ 50,00 all’atto dell’iscrizione al concorso
€ 1.516,00 all’atto dell’immatricolazione
€ 1.150,00 entro 30/06/2019
Iscrizione ai singoli insegnamenti: Si (max 20 CFU) - per i costi vedi scheda informativa - Teaching administration
- Postgraduate Study Unit