Course Name | Pharmaceutical Development and Regulatory Affairs |
Code | Semester | Theory (hour/week) | Application/Lab (hour/week) | Local Credits | ECTS |
---|---|---|---|---|---|
GBE 450 | Fall/Spring | 3 | 0 | 3 | 5 |
Prerequisites | None | |||||
Course Language | English | |||||
Course Type | Elective | |||||
Course Level | First Cycle | |||||
Mode of Delivery | - | |||||
Teaching Methods and Techniques of the Course | ||||||
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;
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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 | ||
Supportive Courses | ||
Media and Managment Skills Courses | ||
Transferable Skill Courses |
Week | Subjects | Required Materials |
1 | Product Life Cycle Management: Stages of New Product Development | Pharmaceutical Product Development, 1st edition, Chapter-1 |
2 | Principal Concepts in Pharmaceutical Product Design and Development | Pharmaceutical Product Development, 1st edition, Chapter-2 |
3 | Regulatory and Intellectual Property Aspects during Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-3 |
4 | Strategies in Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-4 |
5 | Design of Experiments: Basic Concepts and Its Application in Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-5 |
6 | Preformulation Studies: Role in Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-6 |
7 | Midterm exam | |
8 | Formulation Development and Scale-Up | Pharmaceutical Product Development, 1st edition, Chapter-7 |
9 | Process Validation and Postapproval Changes | Pharmaceutical Product Development, 1st edition, Chapter-8 |
10 | Case Studies on Pharmaceutical Product Development | Pharmaceutical Product Development, 1st edition, Chapter-9 |
11 | Packaging of Pharmaceuticals | Pharmaceutical Product Development, 1st edition, Chapter-10 |
12 | Quality Management Systems in Pharmaceutical Manufacturing | Pharmaceutical Product Development, 1st edition, Chapter-11 |
13 | A New Era of Drug Products: Opportunities and Challenges | Pharmaceutical Product Development, 1st edition, Chapter-12 |
14 | Student presentations | |
15 | Review | |
16 | Final exam |
Course Notes/Textbooks | Pharmaceutical Product Development – Insights into Pharmaceutical Process, Management and Regulatory Affairs, 1st Edition. Edited by V Patravale, J Disouza, M Rustomjee. CRC Press. 2016. ISBN: 978-1498730778 |
Suggested Readings/Materials | Continuous manufacturing of Pharmaceuticals, 1st edition. Edited by D. Douroumis, A Fahr, J Siepmann, M Snowden, V Torchilin. Wiley. 2017. ISBN: 978-1-119-00132-4 |
Semester Activities | Number | Weigthing |
Participation | ||
Laboratory / Application | ||
Field Work | ||
Quizzes / Studio Critiques | ||
Portfolio | ||
Homework / Assignments | 1 | 30 |
Presentation / Jury | 1 | 20 |
Project | ||
Seminar / Workshop | ||
Oral Exam | ||
Midterm | 1 | 20 |
Final Exam | 1 | 30 |
Total |
Weighting of Semester Activities on the Final Grade | 3 | 70 |
Weighting of End-of-Semester Activities on the Final Grade | 1 | 30 |
Total |
Semester Activities | Number | Duration (Hours) | Workload |
---|---|---|---|
Course Hours (Including exam week: 16 x total hours) | 16 | 3 | 48 |
Laboratory / Application Hours (Including exam week: 16 x total hours) | 16 | ||
Study Hours Out of Class | 16 | 2 | 32 |
Field Work | |||
Quizzes / Studio Critiques | |||
Portfolio | |||
Homework / Assignments | 1 | 15 | |
Presentation / Jury | 1 | 15 | |
Project | |||
Seminar / Workshop | |||
Oral Exam | |||
Midterms | 1 | 17 | |
Final Exams | 1 | 23 | |
Total | 150 |
# | Program Competencies/Outcomes | * Contribution Level | ||||
1 | 2 | 3 | 4 | 5 | ||
1 | To have adequate knowledge in Mathematics, Science and Biomedical Engineering; to be able to use theoretical and applied information in these areas on complex engineering problems. | |||||
2 | To be able to identify, define, formulate, and solve complex Biomedical Engineering problems; to be able to select and apply proper analysis and modeling methods for this purpose. | |||||
3 | To be able to design a complex system, process, device or product under realistic constraints and conditions, in such a way as to meet the requirements; to be able to apply modern design methods for this purpose. | |||||
4 | To be able to devise, select, and use modern techniques and tools needed for analysis and solution of complex problems in Biomedical Engineering applications. | |||||
5 | To be able to design and conduct experiments, gather data, analyze and interpret results for investigating complex engineering problems or Biomedical Engineering research topics. | |||||
6 | To be able to work efficiently in Biomedical Engineering disciplinary and multi-disciplinary teams; to be able to work individually. | |||||
7 | To be able to communicate effectively in Turkish, both orally and in writing; to be able to author and comprehend written reports, to be able to prepare design and implementation reports, to present effectively, to be able to give and receive clear and comprehensible instructions. | |||||
8 | To have knowledge about global and social impact of Biomedical Engineering practices on health, environment, and safety; to have knowledge about contemporary issues as they pertain to engineering; to be aware of the legal ramifications of engineering solutions. | |||||
9 | To be aware of ethical behavior, professional and ethical responsibility; to have knowledge about standards utilized in engineering applications. | |||||
10 | To have knowledge about industrial practices such as project management, risk management, and change management; to have awareness of entrepreneurship and innovation; to have knowledge about sustainable development. | |||||
11 | To be able to collect data in the area of Biomedical Engineering, and to be able to communicate with colleagues in a foreign language. | |||||
12 | To be able to speak a second foreign language at a medium level of fluency efficiently. | |||||
13 | To recognize the need for lifelong learning; to be able to access information, to be able to stay current with developments in science and technology; to be able to relate the knowledge accumulated throughout the human history to Biomedical Engineering. |
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest