| Course Type | Elective Course |
|---|
| Course Level | Master's Degree Without Thesis |
|---|
| Year of Study | - |
|---|
| Semester | - |
|---|
| ECTS | 5 |
|---|
| Name of Lecturer(s) |
|
| Learning Outcomes |
At the end of this course, the students;
- Learns the concept of pharmacovigilance and understands its importance in terms of public health.
- Have information about adverse drug reactions and monitoring.
- Have knowledge about pharmacovigilance systems in the world and Turkey, about good pharmacovigilance practices.
- Gains skills in adverse effect reporting and risk management.
|
| Mode of Delivery | Face to face |
|---|
| Prerequisites | No |
|---|
| Recommended Optional Programme Components | None |
|---|
| Course Description | To inform the students about the basic concepts of pharmacovigilance, the pharmacovigilance systems in the world and Turkey, good pharmacovigilance practice, to have knowledge about risk management and company responsibilities, to gain skills in adverse reporting and risk management effects. |
|---|
| Course Contents |
| WEEK |
TOPICS |
|
1st Week |
Introduction to pharmacovigilance and its importance in terms of public health |
|
2nd Week |
Adverse drug reactions and related concepts |
|
3rd Week |
Monitoring methods for adverse drug reactions-I: Spontaneous reporting |
|
4th Week |
Monitoring methods for adverse drug reactions-II: Cohort studies |
|
5th Week |
Determining the causality of adverse drug reactions to drugs |
|
6th Week |
Signal management |
|
7th Week |
Mid-term |
|
8th Week |
Pharmacovigilance systems in the world and Turkey |
|
9th Week |
Good Pharmacovigilance Practices |
|
10th Week |
How to Report Suspected Adverse Effects? |
|
11th Week |
Risk Management and Drug Company Responsibilities |
|
12th Week |
Case analysis-I |
|
13th Week |
Case analysis-II |
|
14th Week |
Discussion |
|
| Recommended or Required Reading | 1. Kayaalp, S.O. Klinik Farmakolojinin Esasları ve Temel Düzenlemeler, 3.Baskı, 2005.
2. Thao Doan, Cheryl Renz, Fabio Lievano, Mondira Bhattacharya, Linda Scarazzini, Pharmacovigilance: A practical Approach, 1st edition, 2018.
3. Amrita Akhouri, Mind Maps of Pharmacovigilance Basics, 1st edition, 2018. |
|---|
| Planned Learning Activities and Teaching Methods |
|
|---|
| Assessment Methods and Criteria |
|
Quantity |
Percentage (%) |
| Mid-term |
1 |
20 |
| Assignment |
2 |
15 |
| Other |
2 |
15 |
| Total(%) |
|
50 |
| Contribution of In-term Studies to Overall Grade(%) |
|
50 |
| Contribution of Final Examination to Overall Grade(%) |
|
50 |
| Total(%) |
|
100 |
|
| ECTS Allocated Based on Student Workload |
| Activities |
Quantity |
Duration (Hour) |
Total Workload (Hour) |
| Midterm exam |
1 |
1 |
1 |
| Preparation for Quiz |
0 |
0 |
0 |
| Individual or group work |
14 |
2 |
28 |
| Preparation for Final exam |
1 |
20 |
20 |
| Course hours |
14 |
2 |
28 |
| Preparation for Midterm exam |
1 |
10 |
10 |
| Laboratory (including preparation) |
0 |
0 |
0 |
| Final exam |
1 |
2 |
2 |
| Homework |
2 |
10 |
20 |
| Presentation (including preperation) |
2 |
10 |
20 |
| Literature review |
4 |
3 |
12 |
| Total Work Load | 141 |
| Total Work Load / 30 (h) | 4.7 |
| ECTS Credit of the Course | 5 |
|
| Language of Instruction | Turkish |
|---|
| Work Placement(s) | No |
|---|
