Vaccine safety and vigilance, pharmacoepidemiology, pharmacovigilance

Course Information
TitleΑσφάλεια και επαγρύπνηση εμβολίων, φαρμακοεπιδημιολογία, φαρμακοεπαγρύπνηση / Vaccine safety and vigilance, pharmacoepidemiology, pharmacovigilance
CodeΤΙΜΕΛΝΒ3
FacultyHealth Sciences
SchoolMedicine
Cycle / Level2nd / Postgraduate
Teaching PeriodWinter/Spring
CoordinatorGeorgios Papazisis
CommonNo
StatusActive
Course ID600022195

Programme of Study: DPMS "EMVOLIA KAI LOIMŌDĪ NOSĪMATA" (2022-sīmera)

Registered students: 20
OrientationAttendance TypeSemesterYearECTS
KORMOSCompulsory Course216

Class Information
Academic Year2025 – 2026
Class PeriodSpring
Faculty Instructors
Weekly Hours3
Total Hours39
Class ID
600290163
Course Type 2021
General Foundation
Mode of Delivery
  • Face to face
  • Distance learning
Digital Course Content
Language of Instruction
  • Greek (Instruction, Examination)
Learning Outcomes
- Understand the concept of pharmacovigilance and its basic principles. Specifically, issues related to the safety of traditional chemical drugs, biological drugs, and vaccines. - Understand the process of spontaneous reporting of adverse drug reactions. - Successfully complete the Yellow Card reporting for drugs. - Conduct the process of causality assessment of adverse drug reactions using the WHO methodology. - Understand the benefit/risk ratio in the use of drugs and vaccines.
General Competences
  • Apply knowledge in practice
  • Work in an interdisciplinary team
  • Generate new research ideas
Course Content (Syllabus)
- Basic principles of pharmacovigilance - Safety of chemical drugs - Safety of biological drugs - Safety of vaccines - Safety of COVID-19 vaccines - Placebo effect - Disproportionality analysis - The Yellow Card for drugs - Process of assessing causality of adverse drug reactions
Educational Material Types
  • Notes
Use of Information and Communication Technologies
Use of ICT
  • Use of ICT in Course Teaching
  • Use of ICT in Communication with Students
  • Use of ICT in Student Assessment
Course Organization
ActivitiesWorkloadECTSIndividualTeamworkErasmus
Lectures60
Reading Assigment30
Project
Written assigments15
Exams30
Total135
Student Assessment
Student Assessment methods
  • Written Exam with Multiple Choice Questions (Formative, Summative)
  • Written Exam with Short Answer Questions (Formative, Summative)
  • Oral Exams (Formative, Summative)
Last Update
27-02-2024