EAG605 - ETHICS IN THE DRUG RESEARCH PROCESS
| Course Name | Code | Semester | Theory (hours/week) |
Application (hours/week) |
Credit | ECTS |
|---|---|---|---|---|---|---|
| ETHICS IN THE DRUG RESEARCH PROCESS | EAG605 | Any Semester/Year | 3 | 0 | 3 | 5 |
| Prequisites | ||||||
| Course language | Turkish | |||||
| Course type | Elective | |||||
| Mode of Delivery | Face-to-Face | |||||
| Learning and teaching strategies | Lecture Discussion Preparing and/or Presenting Reports Drill and Practice | |||||
| Instructor (s) | Prof. Dr. Rahime ÅžimÅŸek, Prof. Dr. Oya Ãœnsal Tan | |||||
| Course objective | Global ethics in medical research and ve evaluation standarts of ethical behaviour, ethical behaviour development | |||||
| Learning outcomes |
| |||||
| Course Content | In this course, the global scientific research ethics in medicine, ethical violations and the effect of the unethical situations that may occur in the drug research and development process will be discussed. The course will be offered to contribute to the development of appropriate ethical attitudes. | |||||
| References | 1. Bolton RG, Pharmaceutical Ethics Wiley and Sons Ltd, West Sussex, 2002. 2.Büken, NÖ, Hekim-Endüstri ilişkisi ve Promosyon Etiği, Sağlığın Sesi, www.sagliginsesi.com 3. Büken NÖ, Tıp Etiği Terimleri Sözlüğü, Nisan 2009, Altın Örümcek 4. Gutmann V, A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics" Digital Access to Scholarship at Harvard, Harvard Law School. 5. www.medscape.com 6. Gericke CA, et al, "Ethical Issues in Funding Orphan Drug Research and Development", J. Med. Ethics (2005) 31, 164-168. | |||||
Course outline weekly
| Weeks | Topics |
|---|---|
| Week 1 | Definition of ethical and scientific ethics? |
| Week 2 | Ethic commissions and their operations |
| Week 3 | Evaluation of drug development stages in terms of appropriate ethical behaviour |
| Week 4 | Evaluation of drug development stages in terms of appropriate ethical behaviour |
| Week 5 | Bioethical concept |
| Week 6 | Use of laboratory animals, ethical issues in clinical research |
| Week 7 | Evaluation of ethical drug patent process |
| Week 8 | Ethical issues in multicenter researches |
| Week 9 | Drug promotions and reimbursement system in terms of ethical issues |
| Week 10 | Medical internet ethics |
| Week 11 | Medical internet ethics |
| Week 12 | The unethical behavior examples in drug research |
| Week 13 | Presentation |
| Week 14 | Presentation |
| Week 15 | Recovery |
| Week 16 | Final exam |
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 | 1 | 50 |
| Project | 0 | 0 |
| Seminar | 0 | 0 |
| Midterms | 0 | 0 |
| 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 | 3 | 42 |
| Laboratory | 0 | 0 | 0 |
| Application | 0 | 0 | 0 |
| Specific practical training | 0 | 0 | 0 |
| Field activities | 0 | 0 | 0 |
| Study Hours Out of Class (Preliminary work, reinforcement, ect) | 14 | 4 | 56 |
| Presentation / Seminar Preparation | 1 | 22 | 22 |
| Project | 0 | 0 | 0 |
| Homework assignment | 0 | 0 | 0 |
| Midterms (Study duration) | 0 | 0 | 0 |
| Final Exam (Study duration) | 1 | 30 | 30 |
| Total Workload | 30 | 59 | 150 |
Matrix Of The Course Learning Outcomes Versus Program Outcomes
| D.9. Key Learning Outcomes | Contrubition level* | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | |
| 1. Has knowledge in the area of preformulation and formulation designs about industrial production, quality control, quality assurance system and stability | X | ||||
| 2. Acquires information about nanotechnology, new drug delivery systems and controlled release systems | |||||
| 3. Learns to keep track of up to date literature and patents using the knowledge and informatics technologies | X | ||||
| 4. Interprets the guidelines of health authorities such as FDA, EMA and international guidelines such as GMP, ANDA, BA/BE, QA/QC, acquires application knowledge and skills | X | ||||
| 5. Has knowledge to understand and interpret chemical, instrumental and pharmacological data | X | ||||
| 6. Has basic concepts about medicinal chemistry such as design of new drug molecules, drug-receptor interactions | |||||
| 7. Has the knowledge on the rules of scientific ethics which should be complied | X | ||||
| 8. Effectively uses the conventional and new synthetic methods. | |||||
| 9. Has knowledge of advanced toxicity tests accepted by regulatory authorities | |||||
| 10. Has knowledge about pharmacological experimental methods and their applications used in drug research and evaluates analysis results | X | ||||
| 11. Has knowledge about preclinical and clinical drug research | X | ||||
| 12. Has knowledge about the pharmacokinetic and pharmacodynamic properties of drugs | |||||
| 13. Has knowledge about the pharmacokinetics and pharmacodynamics of drugs | |||||
| 14. Has knowledge of and the ability to use the devices and instruments used in the application of instrumental analysis methods | |||||
| 15. Has the ability to apply theoretical and practical knowledge in the analysis of substances in medicinal products and biological materials | |||||
*1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest