GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION
DRUG REGISTRATION/EE-1050
Course Title: DRUG REGISTRATION
Credits 2 ECTS 7
Semester 2 Compulsory/Elective Elective
COURSE INFO
 -- LANGUAGE OF INSTRUCTION
  Turkish
 -- NAME OF LECTURER(S)
  Prof.Zeynep Şafak TEKSİN, Prof.Sevgi TAKKA
 -- WEB SITE(S) OF LECTURER(S)
  http://websitem.gazi.edu.tr/site/zsteksin, http://websitem.gazi.edu.tr/site/takka
 -- EMAIL(S) OF LECTURER(S)
  zsteksin@gazi.edu.tr, takka@gazi.edu.tr
 -- LEARNING OUTCOMES OF THE COURSE UNIT
Learns the registration procedures to provide the sufficient efficacy, quality and safety.
Learns the drug registration of EMA, FDA and Turkey.
Learns the problems and solutions in the drug registration application
 -- 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  Basic concepts in drug registration (original products, generics etc.,)
2. Week  In the process of licencing practices in Turkey and in the world
3. Week  European drug regulatory process
4. Week  Drug regulatory process in Food Drug Administration (FDA)
5. Week  Drug regulatory process in Turkey Comparison of legal regulations (EMA, FDA & Turkey) on licensing procedures
6. Week  CTD (Common Technical Document) file preparation CTD Module 1, CTD Modül 2
7. Week  CTD Module 3 (DMF-Drug Master File and quality informations)
8. Week  CTD Module 3 (A detailed description of examples of quality informations)
9. Week  CTD Module 4 (Nonclinical overview), CTD 5 (Clinical overview)
10. Week  Variations (type changes) changes
11. Week  Registration procedures of biotechnological and biosimilar products
12. Week  Biosimilar products of licensing regulation in EMA and Turkey
13. Week  Registration procedures of plant-derived products
14. Week  Orphan drugs and registration process
15. Week  
16. Week  
 -- RECOMMENDED OR REQUIRED READING
  EMEA quidance, FDA quidance, ICH quidance, national and international drug registration regulations
 -- 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
 Reading
10
4
40
 Searching in Internet and Library
8
4
32
 Designing and Applying Materials
0
 Preparing Reports
6
5
30
 Preparing Presentation
4
4
16
 Presentation
4
3
12
 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
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