ERU611 - REGISTRATION of BIOLOGICAL PRODUCTS
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| REGISTRATION of BIOLOGICAL PRODUCTS | ERU611 | Spring | 2 | 2 | 3 | 6 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Elective | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Drill and Practice | |||||
| Instructor (s) | Prof.Dr. Sevda Åženel | |||||
| Course objective | To be able to advance those who will work in the field of licensing biological products in terms of technological and preclinical information. | |||||
| Learning outcomes |
| |||||
| Course Content | - Definitions related to biological products - Development and production of biological products (vaccines, allergens, blood products etc.), - Evaluation of biological products with technological aspects - Pre-clinical (preclinical) evaluation methods of biological products - National regulations on licensing biological products - International regulations on licensing biological products - Biosimilar drugs and their licensing | |||||
| References | - Rasyonel tedavi yönünden Tıbbi Farmakoloji (Prof. Dr. Oğuz Kayaalp), - Klinik Farmakolojinin Esasları (Prof. Dr. Oğuz Kayaalp), - Türkiye İlaç Kılavuzu - Drug Information Handbook, - PDR 2006 - EMA guidelines and directives - FDA guidelines - Turkish Medicines and Medical Devices Agency regulations | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Introduction to biological products; basic properties and classification of biological products |
| Week 2 | Technological factors in formulation of biological products (formulation development, manufacturing) |
| Week 3 | National and international regulations regarding the licensing of biological products |
| Week 4 | Pharmacology, toxicology and safety of biological products: vaccines |
| Week 5 | Pharmacology, toxicology and reliability of biological products: blood products. |
| Week 6 | Vaccine products and legal regulations |
| Week 7 | Midterm Exam |
| Week 8 | Biosimilars |
| Week 9 | Licensing of biosimilar products |
| Week 10 | Blood, serum and allergen products and legal regulations: |
| Week 11 | Production processes of biological products |
| Week 12 | Validation and GMP in biological products |
| Week 13 | Assignment presentation |
| Week 14 | Discussion |
| Week 15 | Final xam |
Assesment methods
| Course activities | Number | Percentage |
|---|---|---|
| Attendance | 0 | 0 |
| Laboratory | 0 | 0 |
| Application | 0 | 0 |
| Field activities | 0 | 0 |
| Specific practical training | 0 | 0 |
| Assignments | 0 | 0 |
| Presentation | 0 | 0 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 1 | 50 |
| Final exam | 1 | 50 |
| Total | 100 | |
| Percentage of semester activities contributing grade succes | 1 | 50 |
| Percentage of final exam contributing grade succes | 1 | 50 |
| Total | 100 | |
WORKLOAD AND ECTS CALCULATION
| Activities | Number | Duration (hour) | Total Work Load |
|---|---|---|---|
| Course Duration (x14) | 14 | 2 | 28 |
| Laboratory | 0 | 0 | 0 |
| Application | 14 | 2 | 28 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 14 | 1 | 14 |
| Presentation / Seminar Preparation | 0 | 0 | 0 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 1 | 50 | 50 |
| Final Exam (Study duration) | 1 | 60 | 60 |
| Total Workload | 44 | 115 | 180 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Has basic theoretical concepts and related approaches to provide quality in control systems used in analytical data and method validations | X | ||||
| 2. Has capability to decide conformity tests and to evaluate results by arranging different conditions, planning the activities for method validation and quality control | X | ||||
| 3. Has able to evaluate statistical data used for licensing medicinal products | X | ||||
| 4. Has knowledge on the definition of drug, formulations, properties, production and quality controls | X | ||||
| 5. Has knowledge on pharmaceutical technology in evaluating and/or preparing application dossier of licensing medicines | X | ||||
| 6. Has pharmacological and toxicological knowledge for licensing medicinal products | X | ||||
| 7. Has satisfied knowledge on safely usage of medicines. | X | ||||
| 8. Has basic and technical knowledge about radiopharmaceutics; preparing, evaluating and resulting ability for applied license dossier of radiopharmaceuticals. | X | ||||
| 9. Capable to perform researches on different subjects; can follow published scientific studies; can plan and end a research; able to write a report with the data. | X | ||||
| 10. Has a general idea on pharmaceutical biotechnology. | X | ||||
| 11. Has basic and important pharmacological and toxicological knowledge on biological products. | X | ||||
| 12. Has a general knowledge in registration of natural medicines, medicine out products, cosmetics, and food supplements. | X | ||||
| 13. Capable to discuss and/or defend pharmacoeconomic data in medicine licensing. | X | ||||
| 14. Has basic and technical knowledge about radiopharmacy and has foreknowledge required for prepartio of license dossier of radiopharmaceuticals about radiopharmacy. | |||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest