- University
- Academic
- Schools/Vocational Schools
- Vocational School of Justice
- Vocational School
- Vocational School
- Department of Banking and Insurance (Turkish)
- Department of Computer Programming (Turkish)
- Department of Foreign Trade (Turkish)
- Department of Graphic Design (Turkish)
- Department of Interior Design (Turkish)
- Department of Construction Technology (Turkish)
- Department of Occupational Health and Safety (Turkish)
- Department of Media and Communication (Turkish)
- Department of Architectural Restoration (Turkish)
- Department of Radio and Tv Programming (Turkish)
- Department of Civil Aviation Cabin Services (Turkish)
- Department of Civil Aviation Transportation Management (Turkish)
- Department of Tourism and Hotel Management (Turkish)
- Department of Applied English Translation
- Vocational School Of Health Services
- Vocational School Of Health Services
- Department of Child Development (Turkish)
- Department of Physiotherapy (Turkish)
- Department of Paramedic (Turkish)
- Department of Opticianry (Turkish)
- Department of Medical Documentation and Secreteriat (Turkish)
- Department of Medical Imaging Techniques (Turkish)
- Department of Medical Laboratory Techniques (Turkish)
- Department of Elderly Care (Turkish)
- School of Applied Management Sciences
- School of Foreign Languages
- Faculties
- Faculty of Arts and Sciences
- Faculty of Fine Arts and Design
- Faculty of Law
- Faculty of Communication
- Faculty of Business
- Faculty of Engineering
- Faculty of Engineering
- Department of Computer Engineering
- Department of Biomedical Engineering
- Department of Electrical and Electronics Engineering
- Department of Industrial Engineering
- Department of Food Engineering
- Department of Genetics and Bioengineering
- Department of Aerospace Engineering
- Department of Civil Engineering
- Department of Mechanical Engineering
- Department of Mechatronics Engineering
- Department of Software Engineering
- Faculty of Health Sciences
- Medicine
- Graduate School
- Common Courses
- Schools/Vocational Schools
- Research
- Research Centers
- Library
- Smart Campus
- Technology Transfer Office
- İzmir Sciencepark
- Continuous Education Center (EKOSEM)
- Children's University
- Ethics Committee
- Teaching and Learning Center (EKOEĞİTİM)
- Psychology Application and Research Center
- Researcher Training Coordinatorship
- Research Collaborations And Innovation Coordinatorship
- Campus
- INTERNATIONAL
- Contact
Department of Biomedical Engineering
GBE 450 | Course Introduction and Application Information
| Course Name |
Pharmaceutical Development and Regulatory Affairs
|
|
Code
|
Semester
|
Theory
(hour/week) |
Application/Lab
(hour/week) |
Local Credits
|
ECTS
|
|
GBE 450
|
FALL
|
3
|
0
|
3
|
5
|
| Prerequisites | None | |||||
| Course Language | English | |||||
| Course Type | ELECTIVE_COURSE | |||||
| Course Level | First Cycle | |||||
| Mode of Delivery | Face-To-Face | |||||
| Teaching Methods and Techniques of the Course |
Discussion Group Work Case Study Q&A Lecture / Presentation |
|||||
| National Occupational Classification Code | - | |||||
| Course Coordinator |
|
|||||
| Course Lecturer(s) |
|
|||||
| Assistant(s) | - | |||||
| Course Objectives | The aim of this course is to provide background and insight into the managerial, technical and regulatory aspects of pharmaceutical product development, which in today’s world is stemmed from genetic engineering applications. From this perspective, design of experiments on pharmaceutical product development using molecular biology, genetics and bioengineering techniques will be covered. In addition, extra information will be given on the validation studies and manufacturing technologies as well as regulatory affairs. | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Learning Outcomes |
The students who succeeded in this course;
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
| Course Description | This course describes the managerial process of pharmaceutical product development with examples and case studies by highlighting the technical and regulatory challenges. | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Related Sustainable Development Goals |
-
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
Core Courses |
|
| Major Area Courses |
X
|
|
| Supportive Courses |
|
|
| Media and Managment Skills Courses |
|
|
| Transferable Skill Courses |
|
WEEKLY SUBJECTS AND RELATED PREPARATION STUDIES
| Week | Subjects | Required Materials | Learning Outcome |
| 1 | Product Life Cycle Management: Stages of New Product Development | Pharmaceutical Product Development, 1st edition, Chapter-1 | LO1 |
| 2 | Principal Concepts in Pharmaceutical Product Design and Development | Pharmaceutical Product Development, 1st edition, Chapter-2 | LO1 |
| 3 | Regulatory and Intellectual Property Aspects during Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-3 | LO3 |
| 4 | Strategies in Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-4 | LO2 |
| 5 | Design of Experiments: Basic Concepts and Its Application in Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-5 | LO2 |
| 6 | Preformulation Studies: Role in Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-6 | LO1 |
| 7 | Midterm exam | - | |
| 8 | Formulation Development and Scale-Up | Pharmaceutical Product Development, 1st edition, Chapter-7 | LO4 |
| 9 | Process Validation and Postapproval Changes | Pharmaceutical Product Development, 1st edition, Chapter-8 | LO3 |
| 10 | Process Validation and Postapproval Changes | Pharmaceutical Product Development, 1st edition, Chapter-9 | LO4 |
| 11 | Packaging of Pharmaceuticals | Pharmaceutical Product Development, 1st edition, Chapter-10 | LO4 |
| 12 | Quality Management Systems in Pharmaceutical Manufacturing | Pharmaceutical Product Development, 1st edition, Chapter-11 | LO4 |
| 13 | A New Era of Drug Products: Opportunities and Challenges | Pharmaceutical Product Development, 1st edition, Chapter-12 | LO5 |
| 14 | Student presentations | LO5 | |
| 15 | Semester Review | - | |
| 16 | Final exam | - |
| Course Notes/Textbooks |
Pharmaceutical product development: insights into pharmaceutical processes management and regulatory affairs. 1st Edition. Edited by Patravale et al. CRC Press. 2016. ISBN: 978-1498730778 |
| Suggested Readings/Materials | Continuous manufacturing of pharmaceuticals. 1st Edition. Edited by Douroumis et al. Wiley. 2017. ISBN: 978-1-119-00132-4 |
EVALUATION SYSTEM
| Semester Activities | Number | Weighting | LO1 | LO2 | LO3 | LO4 | LO5 |
| Homework / Assignments | 1 | 30 | X | X | X | ||
| Presentation / Jury | 1 | 20 | X | X | X | ||
| Midterm | 1 | 20 | X | X | X | ||
| Final Exam | 1 | 30 | X | X | |||
| Total | 4 | 100 |
ECTS / WORKLOAD TABLE
| Semester Activities | Number | Duration (Hours) | Workload |
|---|---|---|---|
| Participation | - | - | - |
| Theoretical Course Hours | 16 | 3 | 48 |
| Laboratory / Application Hours | - | - | - |
| Study Hours Out of Class | 16 | 2 | 32 |
| Field Work | - | - | - |
| Quizzes / Studio Critiques | - | - | - |
| Portfolio | - | - | - |
| Homework / Assignments | 1 | 15 | 15 |
| Presentation / Jury | 1 | 15 | 15 |
| Project | - | - | - |
| Seminar / Workshop | - | - | - |
| Oral Exams | - | - | - |
| Midterms | 1 | 17 | 17 |
| Final Exam | 1 | 23 | 23 |
| Total | 150 |
COURSE LEARNING OUTCOMES AND PROGRAM QUALIFICATIONS RELATIONSHIP
| # | PC Sub | Program Competencies/Outcomes | * Contribution Level | ||||
| 1 | 2 | 3 | 4 | 5 | |||
| No program competency data found. | |||||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest
Social Media
Social Media
NEWSALL NEWS
IZMIR UNIVERSITY OF ECONOMICS GÜZELBAHÇE CAMPUS
DetailsGLOBAL CAREER
As Izmir University of Economics transforms into a world-class university, it also raises successful young people with global competence.
More..CONTRIBUTION TO SCIENCE
Izmir University of Economics produces qualified knowledge and competent technologies.
More..VALUING PEOPLE
Izmir University of Economics sees producing social benefit as its reason for existence.
More..
You are one step ahead with your graduate education at Izmir University of Economics.