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ADE - PHARMACOVIGILANCE
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ADE - PHARMACOVIGILANCE
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Academic year 2020/2021
- Course ID
- SCB0392
- Teacher
- Prof. Silvia Anna Racca (Lecturer)
- Year
- 4th year
- Teaching period
- Second semester
- Type
- Elective
- Credits/Recognition
- 1
- Course disciplinary sector (SSD)
- BIO/14 - farmacologia
- Delivery
- Lecture
- Language
- English
- Attendance
- Mandatory
- Type of examination
- Practice test
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Sommario del corso
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Course objectives
To give a good understanding of the basic principles of pharmacovigilance and its activity
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Results of learning outcomes
Students at the end of this ADE will:
-know the national and European legislation on pharmacovigilance.
-know the national pharmacovigilance network and its connections with Europe (EUDRAVIGILANCE) and major worldwide regions (VIGIACCESS/VIGIBASE WHO)
-understand and be able to appropriately apply different epidemiological methods for drug surveillance.
-know the role and responsibilities of pharmacovigilance supervisors and managers in the national health system.
-know how to use adverse drug reaction databases; what and how to report
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Course delivery
Lecture
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Learning assessment methods
Not expected
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Support activities
slides in powerpoint
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Program
Session 1: 3 hrs
- Definitions,and objectives of Pharmacovigilance
- The national pharmacovigilance network: how it works, how to access it, how it fits into the European and global network
- The RAM system (Adverse reactions to medicines database)
- What and how to report
- Practice exercise.
Session 2: 3 hrs
- The Regional Pharmacovigilance Centers
- AIFA Pharmacovigilance projects
- Presentation of some project results
- Final discussion
Suggested readings and bibliography
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Bibliography will be provided during the course
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Note
Maximum number of students: 50
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