At the end of this course, the students; 1) Learns the concept of pharmacovigilance and understands its importance in terms of public health. 2) Have information about adverse drug reactions and monitoring. 3) Have knowledge about pharmacovigilance systems in the world and Turkey, about good pharmacovigilance practices. 4) Gains skills in adverse effect reporting and risk management.
MODE OF DELIVERY
Face to face
PRE-REQUISITES OF THE COURSE
No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT
None
COURSE DEFINITION
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
RECOMENDED 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
Lecture,Discussion
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 WORKLOAD
Activities
Number
Hours
Workload
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 Workload
141
Total Workload / 30
4,7
ECTS Credits of the Course
5
LANGUAGE OF INSTRUCTION
Turkish
WORK PLACEMENT(S)
No
KEY LEARNING OUTCOMES (KLO) / MATRIX OF LEARNING OUTCOMES (LO)
