GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
THE INTELLECTUAL AND INDUSTRIAL PROPERTY RIGHTS IN DRUG AND CHEMICAL ı/EE-1040
Course Title: THE INTELLECTUAL AND INDUSTRIAL PROPERTY RIGHTS IN DRUG AND CHEMICAL ı
Credits 2 ECTS 7
Semester 2 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Assoc.Prof.Zeynep Şafak TEKSİN, Prof. Dr. Füsun Acartürk
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/zsteksin, http://websitem.gazi.edu.tr/site/acarturk
 -- EMAIL(S) OF LECTURER(S)
  zsteksin@gazi.edu.tr, acarturk@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Learning to evaluation of drug patents
To examine data protection and patent related to the current practice and procedures
Learning to application of drug patents
 -- 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  Turkish Pharmaceutical Industry R & D activities, production, investment, consumption and foreign trade in terms of present-day situation
2. Week  History of patent protection in the world and Turkey, the international patent treaties
3. Week  Basic concepts related to patents and data protection, and examination of patent databases
4. Week  Intellectual and industrial property rights in drug
5. Week  Drug patents processability criteria
6. Week  Preparation of patent applications, patent protection and additional documents
7. Week  Compulsory licensing
8. Week  Pharmaceutical data protection
9. Week  The rights of inventors
10. Week  Pharmaceutical patents and generic drugs patent application status
11. Week  The evaluation of drug legislation and patent rights for patent applications in Turkey
12. Week  Legislation relating to international examining patent applications
13. Week  The pharmaceutical market problems in Turkey and the world
14. Week  Pharmaceutical industry R & D and innovation, investment and transformation of patents, licensing and technology transfer for the evaluation of work.
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  EMA guidelines, FDA guidelines, Turkish Patent Institute's guidelines, WIPO guidelines
 -- 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
4
24
 Searching in Internet and Library
6
4
24
 Designing and Applying Materials
0
0
0
 Preparing Reports
5
5
25
 Preparing Presentation
6
5
30
 Presentation
5
5
25
 Mid-Term and Studying for Mid-Term
1
9
9
 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
1Follow the development as having the knowledge and skills in the field of industrial pharmacy, transfer the information to the pharmaceutical industry and develop new approaches in this area.X
2Gains the ability to acess and apply to the health orginazations guidlines such as FDA, EMA, WHO.X
3Preparation and evaluation of the CTD format of the license application to the Turkish Drug and Medical Devices Agency and learn the types of license application made to the other health organizationsX
4Posess the knowledge on the total quality management, GMP, GLP, GSP, QA / QC, process validation, analytical validation and qualification in in the pharmaceutical industry.X
5Learns the concept of systematic R&D, techniques, tools and scale up in drug development.X
6Learns the concept and application of drug formulation development by using quality by design (QbD) and process analytical technology (PAT).X
7Posseses the ability to evaluate and interprete the drug patent databases (TPE, EPO, WIPO etc.)X
8Learns the concept of original and generic drug and the evaluation and interpretation of the study design of bioavalability/bioequivalanceX
9Posess the knowledge and skill about the analytical techniques, method development and validation in the industrial pharmacy.X
10Get the application skill in the releated area by pursuing knowledge in the field of pharmacovigilance and pharmacoeconomics.X
11Develops new approaches to potential problems and bring solutions by using the knowledge in the releated area.X