TÜRKÇE
ENGLISH
Information
| Code | FAR630 |
| Name | |
| Term | 2024-2025 Academic Year |
| Term | Fall and Spring |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 4 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Doktora Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | |
| Course Instructor |
Prof. Dr. YUSUF KARATAŞ
(A Group)
(Ins. in Charge)
Prof. Dr. YUSUF KARATAŞ (A Group) (Ins. in Charge) |
Course Goal / Objective
This session will provide participants with the skills, knowledge, and attitudes necessary to more effectively become practitioners and trainers for identifying, reporting and preventing adverse drug reactions (ADRs) (side effects) to medicines used in healthcare settings.
Course Content
1. Define pharmacovigilance, 2. Explain the importance of pharmacovigilance to assess and improve drug safety, 3. Describe the problems and challenges in conducting pharmacovigilance, 4. Demonstrate how pharmacovigilance methods and risk management strategies can be used to improve patient care.
Course Precondition
no
Resources
1- TÜFAM 2-Medical Pharmacology in Terms of Rational Treatment, Prof. Dr. S. Oğuz Kayaalp, 3-Fundamentals and Basic Regulations of Clinical Pharmacology, Prof. Dr. S. Oğuz Kayaalp, 4th Edition, 2008 4-Goodman&GilmanPharmacological Basis of Treatment
Notes
1- TÜFAM 2-Medical Pharmacology in Terms of Rational Treatment, Prof. Dr. S. Oğuz Kayaalp,
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Understand the importance of pharmacovigilance to assess and improve drug safety |
| LO02 | How pharmacovigilance methods and risk management strategies can be used to improve patient care |
| LO03 | Be able to define pharmacovigilance activities in our country |
| LO04 | Ability to report adverse drug reactions |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Beceriler - Bilişsel, Uygulamalı | Discusses the mechanisms of action, side effects, and toxic effects of drugs. | 1 |
| PLO02 | Beceriler - Bilişsel, Uygulamalı | Explains drug effects, drug interactions and effects on organ systems with a systematic approach | 2 |
| PLO03 | Yetkinlikler - Alana Özgü Yetkinlik | Plans, implements and finalizes a scientific project | |
| PLO04 | Bilgi - Kuramsal, Olgusal | Recognize the research areas and research techniques of pharmacology | 1 |
| PLO05 | Yetkinlikler - Alana Özgü Yetkinlik | Comparatively examines and compiles scientific articles in the field of pharmacology. | 1 |
| PLO06 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Prepares the experimental setup for an in vitro or in vivo pharmacological study and solves problems. | |
| PLO07 | Yetkinlikler - Alana Özgü Yetkinlik | He/she transforms the data obtained from the research project into a scientific research article. | 2 |
| PLO08 | Yetkinlikler - Alana Özgü Yetkinlik | Evaluates drug use and its effects in society due to his/her knowledge about drugs. | 2 |
| PLO09 | Bilgi - Kuramsal, Olgusal | Explain clinical phase studies in drug development. | 1 |
| PLO10 | Beceriler - Bilişsel, Uygulamalı | Evaluates and interprets study data statistically. | |
| PLO11 | Beceriler - Bilişsel, Uygulamalı | contributes to public health with its awareness of rational drug use. | 3 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Pharmacovigilance | Review of relevant chapters and lecture notes of pharmacology books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 2 | Types of Adverse Drug Reactions | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 3 | Concepts related to adverse drug reactions | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 4 | The effects of adverse drug reactions on public health | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 5 | Monitoring the safety of licensed drugs | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 6 | WHO-UMC causality classification | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 7 | Adverse Event Reporting Form | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 8 | Mid-Term Exam | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
|
| 9 | Adverse Event Reporting Form II | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 10 | Development of pharmacovigilance systems | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 11 | Pharmacovigilance Activities in Our Country | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 12 | Pharmacovigilance Contact Point Manager | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 13 | Activities to minimize risk | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 14 | Measures taken by regulatory authorities | Review of relevant chapters of Pharmacology Books and lecture notes. | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Sub-branches of pharmacovigilance | Review of relevant chapters of Pharmacology Books and lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 16 | Term Exams | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
|
| 17 | Term Exams | Ölçme Yöntemleri: Yazılı Sınav, Sözlü Sınav, Ödev |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 2 | 28 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 2 | 28 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 1 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 8 | 8 |
| Final Exam | 1 | 24 | 24 |
| Total Workload (Hour) | 88 | ||
| Total Workload / 25 (h) | 3,52 | ||
| ECTS | 4 ECTS | ||