The Postgraduate Course in Pharmacovigilance aims at providing basic pharmacovigilance knowledge, including the regulatory and organizational aspects that may apply in public or private facilities.
The Course training may be applied in managing pharmacovigilance reports, in bioethical aspects, in pharmaceutical registration and pharmacovigilance of organic drugs, vaccines, biosimilar medicines, phytotherapeutic and cosmetic products.
Moreover, one of the Course’s objectives is to tackle and solve the issues of current pharmacovigilance, regulatory matter and quality assurance issues in facilities.
The Postgraduate Course in Pharmacovigilance delves into topics such as Pharmacology and Pathology, and Pharmaceutical Regulations, and wishes to provide basic pharmacovigilance knowledge that may be applied in public and private structures.
At the end of the Course, students will have the basic elements to judge quality in pharmacovigilance report management independently.
Students may also update their knowledge continuously.
In particular, they will use IT tools to consult databases and scientific literature. A critical and relevant aspect is learning how to manage interaction within the European community in English.
The course includes 50 hours of distance learning divided into 8 days of 6/8 hours each. The course will be divided into four modules of two days (Thursday and Friday). The modules will be distributed over three months.
The Postgraduate Course in Pharmacovigilance trains students on pharmacovigilance in public and private hospital structures, pharmaceutical industries and CRO.
Purpose of the course is helping students gain independence in managing pharmacovigilance processes concerning drugs, biosimilar medicines, vaccines, generics, and phytotherapeutic and cosmetic products.
The Postgraduate Course in Pharmacovigilance includes the following modules:
Module 1: Pharmacology and Pathology
Course unit contents: Pharmacokinetics/pharmacodynamics and Pharmacogenetics/pharmacogenomics. Subpopulations at risk of ADR. Iatrogenic pathology. Introduction to pharmacovigilance.
Module 2: Pharmaceutical legislation (1)
Course unit contents: Development and registration of a drug. Clinical trials, GCP and the role of CROs. The pharmaceutical industry in Italy. EMA and AIFA.
Module 3: Pharmaceutical legislation (2)
Course unit contents: Pharmacovigilance in clinical trials.
Phytovigilance. Cosmetovigilance.
Module 4: Pharmaceutical legislation (3)
Course unit contents: The drug in postmarketing: the private sector.
The general ranking of merit for the academic year 2025/26 will be published on the Italian page of this Course according to the timing provided in the Call.
Information
FAQ
The course will be held entirely on remote, in real time, on Zoom.
The course includes 50 hours of distance learning divided into 8 days of 6/8 hours each. The course will be divided into four modules of two days (Thursday and Friday). The modules will be distributed over three months.
No, there will be no internships/apprenticeships.
Yes, there is a mandatory attendance of at least 70% of the lessons.
Yes, through multiple choice questions relating to each lesson held by the teachers.
Yes, the course will involve 16 professors from the private sector.