Pharmacovigilance: Safety Monitoring, Risk Management and Quality Assurance in the Digital Health Era
2nd level vocational master
A.Y. 2023/2024
Study area
Pharmacy
Master Coordinator
The programme aims to develop professionals with the necessary theoretical and practical knowledge base regarding risk assessment and monitoring of adverse effects associated with a medical treatment.
Each pharmaceutical company operating on the Italian and European market is required to have a pharmacovigilance service for its products, ensuring continuous safety monitoring, updating of safety information, as well as implementation of risk management and risk minimisation plans.
Moreover, the Italian Medicines Agency (AIFA), under the direction of the Ministry of Health, manages the Italian national pharmacovigilance system and the National Pharmacovigilance Network (RNF) for the collection of spontaneous reports, in collaboration with the Regional Centres of Pharmacovigilance and the Local Pharmacovigilance Managers working at local healthcare authorities (ASL), hospitals and scientific institutes for research, hospitalisation and healthcare (IRCCS).
Each pharmaceutical company operating on the Italian and European market is required to have a pharmacovigilance service for its products, ensuring continuous safety monitoring, updating of safety information, as well as implementation of risk management and risk minimisation plans.
Moreover, the Italian Medicines Agency (AIFA), under the direction of the Ministry of Health, manages the Italian national pharmacovigilance system and the National Pharmacovigilance Network (RNF) for the collection of spontaneous reports, in collaboration with the Regional Centres of Pharmacovigilance and the Local Pharmacovigilance Managers working at local healthcare authorities (ASL), hospitals and scientific institutes for research, hospitalisation and healthcare (IRCCS).
To be eligible for the programme, candidates must hold a Master's or Single Cycle degree under Ministerial Decree 270/2004.
Employment opportunities for those who complete the proposed vocational master are to be found in public and private organisations operating within the national and international health services, such as: AIFA; EMA; World Health Organisation; Regional Centres of Pharmacovigilance; local health authorities; hospitals; pharmaceutical companies; universities; contract research organizations; non-profit organizations; pharmacovigilance outsourcing companies.
- Pharmacological and Biomolecular Sciences
Via Balzaretti 9 - 20133 Milano
http://www.sefap.it
[email protected]
+3902/4963.5289 - 02/503.18259
Courses list
Open sessions
| Courses or activities | Professor(s) | ECTS | Total hours | Language |
|---|---|---|---|---|
| Compulsory | ||||
| Biostatistics and Pharmacoepidemiology | 4 | 32 | Italian | |
| Clinical Pharmacology | 4 | 29 | Italian | |
| Design of a Pharmacovigilance Project | 5 | 75 | Italian | |
| Drugs in the Post-Marketing Phase: the Private Sector | 4 | 32 | Italian | |
| Drugs in the Post-Marketing Phase: the Public Sector | 4 | 30 | Italian | |
| Drugs: Clinical Development and Marketing Authorisation | 5 | 35 | Italian | |
| Epidemiological Framework Relating to the Design of Observational Studies | 5 | 75 | Italian | |
| Framework Relating to Pharmacovigilance Methodologies | 8 | 112 | Italian | |
| Pharmacological Framework Relating to the Design of Clinical Trials | 5 | 80 | Italian | |