GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION

DRUG REGISTRATION AND PATENTS/FTE-5020

Course Title:	DRUG REGISTRATION AND PATENTS
Credits	2	ECTS	7
Semester	1	Compulsory/Elective	Elective

COURSE INFO

-- LANGUAGE OF INSTRUCTION

Turkish

-- NAME OF LECTURER(S)

Assoc.Prof.Zeynep Şafak TEKSİN, Prof.Dr.Sevgi Takka

-- WEB SITE(S) OF LECTURER(S)

http://websitem.gazi.edu.tr/site/zsteksin, http://websitem.gazi.edu.tr/site/stakka

-- EMAIL(S) OF LECTURER(S)

zsteksin@gazi.edu.tr, stakka@gazi.edu.tr,

-- LEARNING OUTCOMES OF THE COURSE UNIT

Learning of the applications of drug registration
Learning of the applications of drug patent
Learning of the applications of drug registration and drug patent in Turkey, Europe and US

-- MODE OF DELIVERY

The mode of delivery of this course is Face to face

-- PREREQUISITES AND CO-REQUISITES

There is no prerequisite or co-requisite for this course.

-- RECOMMENDED OPTIONAL PROGRAMME COMPONENTS

There is no recommended optional programme component for this course.

--COURSE CONTENT
1. Week	The aim, content and definations in drug registration
2. Week	The necessary documents which have to be presented in the application of drug registration
3. Week	The abbreviated drug registration
4. Week	Differentiated product applications for licensed products
5. Week	The return of the application and the refusal of drug licence demand
6. Week	The expiration date of licence and re-assessment of the licenced products
7. Week	The registration of drugs in USA and EU.
8. Week	Patent and basic concepts in drug.
9. Week	The history of patent protection in Turkey and The world, The international arrangements about patent
10. Week	The intellectual properties rights
11. Week	The concept of patent in drugs
12. Week	The preparation of the application of patents
13. Week	The types of license in patent
14. Week	The international applications
15. Week
16. Week

-- RECOMMENDED OR REQUIRED READING

FDA Guidance and EMA Guidance

-- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS

Lecture, Question & Answer, Demonstration, Drill - Practise

-- WORK PLACEMENT(S)

-- ASSESSMENT METHODS AND CRITERIA

	Quantity	Percentage
Mid-terms	0	0
Assignment	1	10
Exercises	0	0
Projects	1	50
Practice	0	0
Quiz	0	0
Contribution of In-term Studies to Overall Grade		60
Contribution of Final Examination to Overall Grade		40

-- WORKLOAD

Efficiency	Total Week Count	Weekly Duration (in hour)	Total Workload in Semester
Theoretical Study Hours of Course Per Week	14	2	28
Practising Hours of Course Per Week	0	0	0
Reading	6	5	30
Searching in Internet and Library	6	5	30
Designing and Applying Materials	0	0	0
Preparing Reports	5	8	40
Preparing Presentation	2	7	14
Presentation	2	8	16
Mid-Term and Studying for Mid-Term	1	7	7
Final and Studying for Final	1	10	10
Other			0
TOTAL WORKLOAD:			175
TOTAL WORKLOAD / 25:			7
ECTS:			7

-- 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

Gazi University

Information Package

Programme Information

Search

GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR