Pharmacoepidemiology - Pharmacovigilance

Course Information
TitleΦαρμακοεπιδημιολογία - Φαρμακοεπαγρύπνηση / Pharmacoepidemiology - Pharmacovigilance
FacultyHealth Sciences
Cycle / Level2nd / Postgraduate
Teaching PeriodSpring
CoordinatorGeorgios Papazisis
Course ID600015225

Programme of Study: PPS Clinical and Industrial Pharmacology - Clinical Toxicology

Registered students: 34
OrientationAttendance TypeSemesterYearECTS
Clinical Pharmacology and Pharmaceutical MedicineCompulsory Course belonging to the selected specialization (Compulsory Specialization Course)215
Industrial PharmacologyCompulsory Course belonging to the selected specialization (Compulsory Specialization Course)215
Clinical ToxicologyCompulsory Course belonging to the selected specialization (Compulsory Specialization Course)215

Class Information
Academic Year2022 – 2023
Class PeriodSpring
Faculty Instructors
Instructors from Other Categories
Weekly Hours2
Class ID
Course Type 2011-2015
Specific Foundation / Core
Mode of Delivery
  • Face to face
  • Distance learning
Digital Course Content
Language of Instruction
  • Greek (Instruction, Examination)
  • English (Instruction, Examination)
Required Courses
  • ΜΙΦΑ0017 Philosophy, Ethics and drug Legislation.
  • ΜΙΦΑ0018 Basic principles and concepts of Phrarmacology
  • ΜΙΦΑ0019 Pharmaceutical research and drug development.
  • ΜΙΦΑ0020 Biostatistics I
  • ΜΙΦΑ0021 Bioinformatics- Biostatistics II
  • ΜΙΦΑ0022 Research Methodology and Evidence Based Medicine
  • ΜΙΦΑ0023 Clinical Pharmacology I
General Prerequisites
Κnowledge of Clinical Pharmacology
Learning Outcomes
To design a clinical pharmacoepidemiology study Group working Improve ADR reporting culture Minimizing medication errors Training of the Health Care professional to fill and submit successfully the national reporting form Educating post-graduate students on PV and developing a positive ADR reporting culture Training on causality assessment WHO-UMC causality assessment scale
General Competences
  • Apply knowledge in practice
  • Retrieve, analyse and synthesise data and information, with the use of necessary technologies
  • Adapt to new situations
  • Make decisions
  • Work autonomously
  • Work in teams
  • Work in an international context
  • Work in an interdisciplinary team
  • Design and manage projects
Course Content (Syllabus)
Introduction into Pharmacoepidemiology Inspiration by harm in individual patient Occurrence relation Causality, counfounding, channeling Pharmacoepidemiological study design Group work: design your study Introduction into Pharmacovigilance Developing a positive ADR reporting culture PV methods Mechanisms of ADR and risk factors Signal detection Using real world data to detect safety signals Logic of causality and single case assessment Statistical methods in signal detection The yellow card scheme of EOF (theory and training)
pharmacoepidemiology, pharmacovigilance, drug safety, patient safety, adverse drug reactions, clinical study design, yellow card scheme
Educational Material Types
  • Notes
  • Slide presentations
  • Interactive excersises
Use of Information and Communication Technologies
Use of ICT
  • Use of ICT in Course Teaching
  • Use of ICT in Communication with Students
Course Organization
Laboratory Work
Reading Assigment
Student Assessment
Student Assessment methods
  • Written Exam with Multiple Choice Questions (Summative)
  • Oral Exams (Summative)
  • Written Exam with Problem Solving (Summative)
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