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
1		X
2		X
3			X
4				X
5			X
6		X
7			X
8		X
9				X
10		X
11					X
12		X
13
14		X
15				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)

Gazi University

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GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR