GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
PHARMACOVIGILANCE/FRL-4070
Course Title: PHARMACOVIGILANCE
Credits 2 ECTS 6
Course Semester 1 Type of The Course Elective
COURSE INFORMATION
 -- (CATALOG CONTENT)
 -- (TEXTBOOK)
 -- (SUPPLEMENTARY TEXTBOOK)
 -- (PREREQUISITES AND CO-REQUISITES)
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- COURSE OBJECTIVES
 -- COURSE LEARNING OUTCOMES
Knows the importance of the pharmacovigilance in Turkey and the world.
Be able to provide feedback on adverse drug reactions.
Knows pharmacovigilance regulation.
Knows the The World Health Organization pharmacovigilance center and TUFAM.

 -- MODE OF DELIVERY
  The mode of delivery of this course is face to face.
 --WEEKLY SCHEDULE
1. Week  Basic terms related to pharmacovigilance
2. Week  Adverse drug reactions and basic terms
3. Week  Differences between adverse reaction, advers event and similiar terms
4. Week  Data mining and signal
5. Week  Toxicity tests and foresight in animals
6. Week  Importance of phase 4 studies in respect of toxicity tests in human
7. Week  Incidance and risk
8. Week  World pharmacovigilance systems
9. Week  WHO and European Union pharmacovigilance systems
10. Week  National pharmacovigilance Centre
11. Week  Pharmacovigilance application guideline and intrnational examples
12. Week  Basic of pharmacoepidemiology
13. Week  Pharmacovigilance regulation
14. Week  Exam
15. Week  
16. Week  
 -- TEACHING and LEARNING METHODS
 -- ASSESSMENT CRITERIA
 
Quantity
Total Weighting (%)
 Midterm Exams
1
50
 Assignment
0
0
 Application
0
0
 Projects
0
0
 Practice
0
0
 Quiz
0
0
 Percent of In-term Studies  
50
 Percentage of Final Exam to Total Score  
50
 -- WORKLOAD
 Activity  Total Number of Weeks  Duration (weekly hour)  Total Period Work Load
 Weekly Theoretical Course Hours
14
2
28
 Weekly Tutorial Hours
0
 Reading Tasks
5
5
25
 Searching in Internet and Library
5
5
25
 Material Design and Implementation
4
4
16
 Report Preparing
4
3
12
 Preparing a Presentation
2
3
6
 Presentation
1
2
2
 Midterm Exam and Preperation for Midterm Exam
2
5
10
 Final Exam and Preperation for Final Exam
2
10
20
 Other (should be emphasized)
3
2
6
 TOTAL WORKLOAD: 
150
 TOTAL WORKLOAD / 25: 
6
 Course Credit (ECTS): 
6
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1X
2X
3
4
5
6
7
8
9X
10X
11
12
13
14X
 -- NAME OF LECTURER(S)
   (Prof. Dr. MECIT ORHAN ULUDAG)
 -- WEB SITE(S) OF LECTURER(S)
   (http://websitem.gazi.edu.tr/site/uludag)
 -- EMAIL(S) OF LECTURER(S)
   (uludag@gazi.edu.tr)