TÜRKÇE
ENGLISH
Information
| Code | EFR515 |
| Name | |
| Term | 2024-2025 Academic Year |
| Term | Fall and Spring |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 3 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Yüksek Lisans Dersi |
| Type | Normal |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | |
| Course Instructor |
Doç. Dr. HACER SİNEM BÜYÜKNACAR
(A Group)
(Ins. in Charge)
|
Course Goal / Objective
At the end of this course, students explain the concepts of pharmacovigilance and adverse drug reactions, types of adverse reactions, the importance of pharmacovigilance, pharmacovigilance activities, Turkish pharmacovigilance system, methods of monitoring adverse drugs in pharmacovigilance activities.
Course Content
Concepts related to pharmacovigilance and adverse drug reactions, types of adverse reactions, importance of pharmacovigilance studies in terms of public health, pharmacovigilance systems, pharmacovigilance system in Turkey, methods of monitoring adverse drug reactions in pharmacovigilance activities, recording, evaluation, archiving.
Course Precondition
None
Resources
1-Kayaalp S. Oğuz. Principles of Clinical Pharmacology and Basic Regulations, Pelikan publications,2013. 2-Kayaalp S. Oğuz .Medical Pharmacology in Terms of Rational Treatment Volume 1 and 2 Pelikan Publications,2019 3-Katzung Bertram G. Basic- Clinical Pharmacology McGraw-Hill Medical Books,2018.
Notes
pubmed
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Defines concepts related to pharmacovigilance and adverse drug reaction. |
| LO02 | Defines the activities carried out within the framework of pharmacovigilance. |
| LO03 | Explain the importance of pharmacovigilance studies in terms of public health. |
| LO04 | Explains pharmacovigilance systems. |
| LO05 | Explain the pharmacovigilance system in Turkey. |
| LO06 | Counts the methods of monitoring adverse drug reaction. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Explain the mechanisms of action of drugs, their pharmacokinetic and pharmacodynamic effects. | 3 |
| PLO02 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Acts in accordance with ethical and legal principles in the field of pharmacology. | |
| PLO03 | Beceriler - Bilişsel, Uygulamalı | Can project and conduct research in the field of pharmacology and analyze and interpret data. | |
| PLO04 | Yetkinlikler - Alana Özgü Yetkinlik | It plays an active role in rational drug use and provides counseling to the patient for the correct use of the drug. | 2 |
| PLO05 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Can convey the current developments or studies in the field of pharmacology verbally or in writing. | 4 |
| PLO06 | Bilgi - Kuramsal, Olgusal | Follows scientific literature and current developments in the field of pharmacology. | 4 |
| PLO07 | Bilgi - Kuramsal, Olgusal | Establishes a relationship between the effects, mechanisms of action and drug interactions of drugs. | 3 |
| PLO08 | Bilgi - Kuramsal, Olgusal | Explain the physiopathology of various diseases and evalue the drugs used in the treatment of these diseases. | |
| PLO09 | Beceriler - Bilişsel, Uygulamalı | Knows and uses good laboratory practices. | |
| PLO10 | Beceriler - Bilişsel, Uygulamalı | Uses the theoretical and applied knowledge gained in the field of pharmacology. | |
| PLO11 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Have the ability to take part in in vitro/in vivo animal studies. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Course introduction and application, explanation of evaluation information to the student. | Reading related books | Öğretim Yöntemleri: Anlatım |
| 2 | Pharmacovigilance and Adverse Drug Reaction | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 3 | Importance of Pharmacovigilance in terms of Public Health | Reading related books | Öğretim Yöntemleri: Anlatım, Tartışma |
| 4 | Pharmacovigilance Systems | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 5 | Current Pharmacovigilance Research | Reading related books | Öğretim Yöntemleri: Anlatım, Tartışma, Soru-Cevap |
| 6 | Pharmacovigilance System in Turkey | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 7 | Monitoring Adverse Drug Reaction: Spontaneous Reporting Systems | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 8 | Mid-Term Exam | Repetition of course topics | Ölçme Yöntemleri: Sözlü Sınav, Ödev, Performans Değerlendirmesi |
| 9 | Monitoring of Adverse Drug Reaction: Notifications that companies are obliged to make | Reading related books | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası, Soru-Cevap |
| 10 | Adverse Drug Reaction Monitoring: Adverse drug reaction monitoring with cohort studies | Reading related books | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 11 | Adverse Drug Reaction Monitoring: Adverse drug reaction monitoring with case-control studies | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Beyin Fırtınası |
| 12 | Periodic Benefit/Risk Assessment | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 13 | Risk management | Reading related books | Öğretim Yöntemleri: Anlatım, Beyin Fırtınası |
| 14 | Signal Management | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Student presentations | Reading related books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Beyin Fırtınası |
| 16 | Term Exams | General review | Ölçme Yöntemleri: Yazılı Sınav |
| 17 | Term Exams | General review | Ölçme Yöntemleri: Yazılı Sınav |
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 | 3 | 42 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 4 | 4 |
| Final Exam | 1 | 8 | 8 |
| Total Workload (Hour) | 82 | ||
| Total Workload / 25 (h) | 3,28 | ||
| ECTS | 3 ECTS | ||