GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
REGULATION TOXICOLOGY/FTO-1070
Course Title: REGULATION TOXICOLOGY
Credits 3 ECTS 7.5
Course Semester 2 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
Awareness of the national and international regulations of chemical, physical and biological compounds.
Learning how to follow developments, changes in the regulations in its dynamic structure.
Competence in directives and guidelines with regards to each chemical group regulation like drugs, cosmetics, food additives.
Observation of the use of alternative methods in regulations.
 -- MODE OF DELIVERY
  The mode of delivery of this course is face to face
 --WEEKLY SCHEDULE
1. Week  Historical perspective in regulatory toxicology
2. Week  Overview to the aim of regulations and the involvement of toxicology and toxicologist in the regulations
3. Week  Currently used toxicology tests and ethical concern of animal welfare in the regulations
4. Week  Safety evaluation approaches in regulatory system (tiered approach)
5. Week  Alternative toxicity tests, organizations for alternative test development and validation(i.e. ECVAM, ICCVAM, JACVAM)
6. Week  What is REACH? Aims and the regular process to achieve these aims and priorities
7. Week  Midterm exam, htask presentation
8. Week  Test guidelines (i.e. OECD, ICH) and harmonization system considering the regulatory aims
9. Week  Quality assurance in regulations
10. Week  Regulatory organizations- i.e. EU, USA, Japan, Canada I
11. Week  Regulatory organizations- i.e. EU, USA, Japan, Canada II
12. Week  Regulatory organizations- Turkey
13. Week  Regulations for pharmaceuticals, medical devices and cosmetics
14. Week  Regulations for industrial chemicals, pesticides, veterinary drugs, food additives and other highlighting chemical groups
15. Week  Task Presentation
16. Week  Final exam
 -- TEACHING and LEARNING METHODS
 -- ASSESSMENT CRITERIA
 
Quantity
Total Weighting (%)
 Midterm Exams
1
30
 Assignment
2
20
 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
13
3
39
 Weekly Tutorial Hours
0
0
0
 Reading Tasks
10
5
50
 Searching in Internet and Library
3
6
18
 Material Design and Implementation
0
0
0
 Report Preparing
0
0
0
 Preparing a Presentation
2
15
30
 Presentation
2
4
8
 Midterm Exam and Preperation for Midterm Exam
1
21
21
 Final Exam and Preperation for Final Exam
1
21
21
 Other (should be emphasized)
0
0
0
 TOTAL WORKLOAD: 
187
 TOTAL WORKLOAD / 25: 
7.48
 Course Credit (ECTS): 
7.5
 -- COURSE'S CONTRIBUTION TO PROGRAM
NO
 PROGRAM LEARNING OUTCOMES
1
2
3
4
5
1The ability to understand the principles of toxicologyX
2The ability to design and conduct experiments, to evaluate and interpret critically toxicity data.X
3Effectively use acquired laboratory skills in toxicological researchX
4The ability to use necessary techniques and modern analysis tools for toxicological analysis practiceX
5Undertake complex toxicology data analysis, the ability to analyze, synthesize and evaluate new ideasX
6The ability to work effectively as an individual, in teams, and in multidisciplinaryX
7Display excellence and innovation in problem-solving skills, demonstrate a sophisticated level of interpretation and the ability to communicate both orally and in writing at a high level of proficiencyX
8The ability to evaluate and to apply human health risks caused by drugs and other chemicals. Perform complicated chemical risk assessments.X
9The ability of monitoring, searching and evaluating the advers drug effectsX
10To know the principles of first aid and treatment of poisoning and the ability to make the effective guidance
11Be able to describe thoroughly the chemical concentration/dose to the observed toxicity effects and to understand the mode of action of the chemicals or its metabolites in living organismsX
12To understand the mechanisms of the production of the free radicals, oxidative stress and the relation of the radicals to the xenobiotic metabolism and their toxicological significance
13Gaining knowledge on the immune system, effects of the xenobiotics on the immune system, pathological alterations of the biological system due to these alterations.
14To achieve current knowledge and awareness with regards to the national and international regulation of chemical, physical and biological agents and use of toxicology data in regulation approach.X
15To learn application and evaluation of toxic effects of chemicals by in vivo and in vitro test systems.X
 -- NAME OF LECTURER(S)
   (Prof. Dr. Gonca ÇAKMAK )
 -- WEB SITE(S) OF LECTURER(S)
   (-)
 -- EMAIL(S) OF LECTURER(S)
   (gcakmak@gazi.edu.tr , goncacd@gmail.com)