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| ECZ4000 | Drug Safety and Pharmacovigilance | 2+0+0 | ECTS:4 | | Year / Semester | Spring Semester | | Level of Course | Second Cycle | | Status | Elective | | Department | DEPARTMENT of PHARMACEUTICS | | Prerequisites and co-requisites | None | | Mode of Delivery | Face to face, Group study | | Contact Hours | 14 weeks - 2 hours of lectures per week | | Lecturer | Dr. Öğr. Üyesi Yeşim KAYA YAŞAR | | Co-Lecturer | Doç Dr. Gülin Renda, Dr. Öğr. Üyesi Yeşim Kaya Yaşar | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | To learn the basic principles of drug safety and pharmacovigilance; and also the pharmacist' responsibilities in pharmacovigilance process. |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Define the basic concepts related to drug safety | | | | LO - 2 : | Describe the drug-related adverse event and adverse effect | | | | LO - 3 : | Define adverse drug reactions and group important adverse drug reactions by giving examples | | | | LO - 4 : | Have knowledge about basic principles of pharmacovigilance | | | | LO - 5 : | Have knowledge of pharmacovigilance studies in herbal products | | | | LO - 6 : | Gains knowledge of the role of the pharmacist in the pharmacovigilance process | | | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), LO : Learning Outcome | | |
| Basic concepts related to drug safety, adverse event and adverse effect definitions, basic principles of drug safety and adverse drug reactions, basic principles of pharmacovigilance
Legal regulations, international collaboration, ethical and social consideration, pharmacovigilance application of medicinal products
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Pharmacovigilance-introduction | | | Week 2 | Pharmacovigilance-introduction | | | Week 3 | Basic principles | | | Week 4 | Drug safety and adverse drug reactions-1 | | | Week 5 | Drug safety and adverse drug reactions-2 | | | Week 6 | Types and sources of data | | | Week 7 | The process of pharmacovigilance | | | Week 8 | Legal regulations on pharmacovigilance | | | Week 9 | Mid-exam | | | Week 10 | International collaboration | | | Week 11 | Ethical and social considerations | | | Week 12 | Pharmacovigilance in herbal products | | | Week 13 | Presentations | | | Week 14 | Presentations | | | Week 15 | Presentations | | | Week 16 | Exam | | | |
| 1 | Waller, P. 2010 An introduction to Pharmacovigilance Wiley-Blackwell | | | |
| 1 | Mann, R., Andrews, E. 2007 Pharmacovigilance, Wiley | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 8 | 07/04/2020 | 2 | 40 | | Homework/Assignment/Term-paper | 3 | 28/04/2020
05
/05/2020
12/05/2020 | 2 | 30 | | End-of-term exam | 3 | 19/05/2020 | 2 | 30 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 2 | 11 | 22 | | Arasınav için hazırlık | 2 | 6 | 12 | | Arasınav | 1 | 1 | 1 | | Ödev | 2 | 3 | 6 | | Dönem sonu sınavı için hazırlık | 3 | 6 | 18 | | Dönem sonu sınavı | 1 | 1 | 1 | | Total work load | | | 60 |
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