Course Detail
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PHARMACEUTICAL LEGISLATION and MANAGEMENT | ECF5213311 | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Required |
| Course Coordinator | Assoc.Prof. Tuba DÜZCÜ |
| Name of Lecturer(s) | Prof.Dr. Kerime Arzu BALOĞLU, Assist.Prof. Aygül KÖSEOĞLU, Assoc.Prof. Tuba DÜZCÜ |
| Assistant(s) | |
| Aim | To equip the student with competence in pharmaceutical legislation, licensing procedures, and regulatory mechanisms in force in Turkey To teach the business dimensions, such as the establishment of community/hospital pharmacies, financial management, quality assurance, and human resources To provide knowledge about the supply and distribution chain processes of medicines and health products, as well as the related responsibilities. |
| Course Content | This course contains; Law on Pharmacies and Pharmacists,Turkish Pharmacists' Association Law, Basic Regulations Related to Pharmacy,Cosmetics Law, Cosmetics Regulation, Traditional Herbal Medicinal Products Regulation, Traditional and Complementary Medicine Practices Regulation,Legal Responsibilities of the Pharmacist,The Role and Importance of Business Science in Pharmacy,Pharmacist as a Manager and Their Duties,Pharmacy as a Business and Ethics,Requirements for Opening a Pharmacy, Pharmacy Location, Relationships with Stakeholders,Shelf Arrangement and Stock Management in the Pharmacy,Pharmacist-Patient Relationships, SGK Medula System,Personnel Recruitment and Management,Financial Transactions in the Pharmacy,Financial Transactions, Financial Statements, and Analyzes in the Pharmacy,Basic Principles of Accounting and Accounting Information System. |
| Course Learning Outcomes | Teaching Methods | Assessment Methods |
| 1. Will be able to plan the bureaucratic procedures to be done while opening a pharmacy | 12, 14, 4, 9 | C |
| 1.1. He/She carries out the license procedures at the opening of the pharmacy. | 12, 14, 4, 9 | C |
| 1.2. Defines relations with stakeholders after obtaining license | 12, 14, 4, 9 | C |
| 1.3. Supervises the personnel and information systems necessary to ensure the internal order of the pharmacy. | 12, 14, 4, 9 | C |
| 2. Will be able to evaluate the financial and legal transactions to be made in the pharmacy business. | 12, 14, 4, 9 | C |
| 2.1. Plans financial transactions in the pharmacy. | 12, 14, 4, 9 | C |
| 2.2. Interprets the usage areas and legal responsibilities of legal documents used in pharmacy. | 12, 14, 4, 9 | C |
| 2.3. Interprets the contents and control of the systems used in the pharmacy. | 12, 14, 4, 9 | C |
| Teaching Methods: | 12: Problem Solving Method, 14: Self Study Method, 4: Inquiry-Based Learning, 9: Lecture Method |
| Assessment Methods: | C: Multiple-Choice Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Law on Pharmacies and Pharmacists | 1,2,3,4 |
| 2 | Turkish Pharmacists' Association Law, Basic Regulations Related to Pharmacy | 1,2,3,4 |
| 3 | Cosmetics Law, Cosmetics Regulation, Traditional Herbal Medicinal Products Regulation, Traditional and Complementary Medicine Practices Regulation | 1,2,3,4 |
| 4 | Legal Responsibilities of the Pharmacist | 1,2,3,4 |
| 5 | The Role and Importance of Business Science in Pharmacy | 1,2,3,4 |
| 6 | Pharmacist as a Manager and Their Duties | 1,2,3,4 |
| 7 | Pharmacy as a Business and Ethics | 1,2,3,4 |
| 8 | Requirements for Opening a Pharmacy, Pharmacy Location, Relationships with Stakeholders | 1,2,3,4 |
| 9 | Shelf Arrangement and Stock Management in the Pharmacy | 1,2,3,4 |
| 10 | Pharmacist-Patient Relationships, SGK Medula System | 1,2,3,4 |
| 11 | Personnel Recruitment and Management | 1,2,3,4 |
| 12 | Financial Transactions in the Pharmacy | 1,2,3,4 |
| 13 | Financial Transactions, Financial Statements, and Analyzes in the Pharmacy | 1,2,3,4 |
| 14 | Basic Principles of Accounting and Accounting Information System | 1,2,3,4 |
| Resources |
| 1. Course notes will be given to students. 2. Güçlü Eczane Yönetimi, Faruk Nalbantoğlu, Artifarma Publications,2014 3. Operations Management: Processes and Supply Chains, 14th Edition. Lee J. Krajewski, Manoj K. Malhotra. 2025 4. Essentials of Pharmacy Management, Dennis H Toolelian, Albert Wertheimer, Andrey Mikhailitchenko, Pharmaceutical Press, 2012 5. Özçelikay G., Çalıkuşu M., Uzun M.B. (2023), Eczacılıkta İşletme Yönetimi, Akademisyen Kitabevi, Ankara. 6.Yeğenoğlu, S., Şencan N. (2024). Eczacılık İşletmeciliği Akıl Notları, Güneş Tıp Kitabevleri, Ankara. 7. Özçelikay G., Şencan N. (2015). Eczacılık İşletmeciliği, Akademisyen Tıp Kitabevi, Ankara. |
| - |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | ||||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | X | |||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | X | |||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | X | |||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | ||||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | ||||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | ||||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | ||||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |
| ECTS / Workload Table | ||||||
| Activities | Number of | Duration(Hour) | Total Workload(Hour) | |||
| Course Hours | 14 | 2 | 28 | |||
| Guided Problem Solving | 14 | 2 | 28 | |||
| Resolution of Homework Problems and Submission as a Report | 0 | 0 | 0 | |||
| Term Project | 0 | 0 | 0 | |||
| Presentation of Project / Seminar | 0 | 0 | 0 | |||
| Quiz | 0 | 0 | 0 | |||
| Midterm Exam | 1 | 11 | 11 | |||
| General Exam | 1 | 11 | 11 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 78 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(78/30) | 3 | |||||
| ECTS of the course: 30 hours of work is counted as 1 ECTS credit. | ||||||
Detail Informations of the Course
Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PHARMACEUTICAL LEGISLATION and MANAGEMENT | ECF5213311 | Spring Semester | 2+0 | 2 | 3 |
| Course Program |
| Prerequisites Courses | |
| Recommended Elective Courses |
| Language of Course | Turkish |
| Course Level | First Cycle (Bachelor's Degree) |
| Course Type | Required |
| Course Coordinator | Assoc.Prof. Tuba DÜZCÜ |
| Name of Lecturer(s) | Prof.Dr. Kerime Arzu BALOĞLU, Assist.Prof. Aygül KÖSEOĞLU, Assoc.Prof. Tuba DÜZCÜ |
| Assistant(s) | |
| Aim | To equip the student with competence in pharmaceutical legislation, licensing procedures, and regulatory mechanisms in force in Turkey To teach the business dimensions, such as the establishment of community/hospital pharmacies, financial management, quality assurance, and human resources To provide knowledge about the supply and distribution chain processes of medicines and health products, as well as the related responsibilities. |
| Course Content | This course contains; Law on Pharmacies and Pharmacists,Turkish Pharmacists' Association Law, Basic Regulations Related to Pharmacy,Cosmetics Law, Cosmetics Regulation, Traditional Herbal Medicinal Products Regulation, Traditional and Complementary Medicine Practices Regulation,Legal Responsibilities of the Pharmacist,The Role and Importance of Business Science in Pharmacy,Pharmacist as a Manager and Their Duties,Pharmacy as a Business and Ethics,Requirements for Opening a Pharmacy, Pharmacy Location, Relationships with Stakeholders,Shelf Arrangement and Stock Management in the Pharmacy,Pharmacist-Patient Relationships, SGK Medula System,Personnel Recruitment and Management,Financial Transactions in the Pharmacy,Financial Transactions, Financial Statements, and Analyzes in the Pharmacy,Basic Principles of Accounting and Accounting Information System. |
| Course Learning Outcomes | Teaching Methods | Assessment Methods |
| 1. Will be able to plan the bureaucratic procedures to be done while opening a pharmacy | 12, 14, 4, 9 | C |
| 1.1. He/She carries out the license procedures at the opening of the pharmacy. | 12, 14, 4, 9 | C |
| 1.2. Defines relations with stakeholders after obtaining license | 12, 14, 4, 9 | C |
| 1.3. Supervises the personnel and information systems necessary to ensure the internal order of the pharmacy. | 12, 14, 4, 9 | C |
| 2. Will be able to evaluate the financial and legal transactions to be made in the pharmacy business. | 12, 14, 4, 9 | C |
| 2.1. Plans financial transactions in the pharmacy. | 12, 14, 4, 9 | C |
| 2.2. Interprets the usage areas and legal responsibilities of legal documents used in pharmacy. | 12, 14, 4, 9 | C |
| 2.3. Interprets the contents and control of the systems used in the pharmacy. | 12, 14, 4, 9 | C |
| Teaching Methods: | 12: Problem Solving Method, 14: Self Study Method, 4: Inquiry-Based Learning, 9: Lecture Method |
| Assessment Methods: | C: Multiple-Choice Exam |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | Law on Pharmacies and Pharmacists | 1,2,3,4 |
| 2 | Turkish Pharmacists' Association Law, Basic Regulations Related to Pharmacy | 1,2,3,4 |
| 3 | Cosmetics Law, Cosmetics Regulation, Traditional Herbal Medicinal Products Regulation, Traditional and Complementary Medicine Practices Regulation | 1,2,3,4 |
| 4 | Legal Responsibilities of the Pharmacist | 1,2,3,4 |
| 5 | The Role and Importance of Business Science in Pharmacy | 1,2,3,4 |
| 6 | Pharmacist as a Manager and Their Duties | 1,2,3,4 |
| 7 | Pharmacy as a Business and Ethics | 1,2,3,4 |
| 8 | Requirements for Opening a Pharmacy, Pharmacy Location, Relationships with Stakeholders | 1,2,3,4 |
| 9 | Shelf Arrangement and Stock Management in the Pharmacy | 1,2,3,4 |
| 10 | Pharmacist-Patient Relationships, SGK Medula System | 1,2,3,4 |
| 11 | Personnel Recruitment and Management | 1,2,3,4 |
| 12 | Financial Transactions in the Pharmacy | 1,2,3,4 |
| 13 | Financial Transactions, Financial Statements, and Analyzes in the Pharmacy | 1,2,3,4 |
| 14 | Basic Principles of Accounting and Accounting Information System | 1,2,3,4 |
| Resources |
| 1. Course notes will be given to students. 2. Güçlü Eczane Yönetimi, Faruk Nalbantoğlu, Artifarma Publications,2014 3. Operations Management: Processes and Supply Chains, 14th Edition. Lee J. Krajewski, Manoj K. Malhotra. 2025 4. Essentials of Pharmacy Management, Dennis H Toolelian, Albert Wertheimer, Andrey Mikhailitchenko, Pharmaceutical Press, 2012 5. Özçelikay G., Çalıkuşu M., Uzun M.B. (2023), Eczacılıkta İşletme Yönetimi, Akademisyen Kitabevi, Ankara. 6.Yeğenoğlu, S., Şencan N. (2024). Eczacılık İşletmeciliği Akıl Notları, Güneş Tıp Kitabevleri, Ankara. 7. Özçelikay G., Şencan N. (2015). Eczacılık İşletmeciliği, Akademisyen Tıp Kitabevi, Ankara. |
| - |
Course Contribution to Program Qualifications
| Course Contribution to Program Qualifications | |||||||
| No | Program Qualification | Contribution Level | |||||
| 1 | 2 | 3 | 4 | 5 | |||
| 1 | PQ-1. Skilfully use information technology to access, follow, evaluate and apply current knowledge in the field of Pharmaceutical Sciences. | X | |||||
| 2 | PQ-2. Have advanced knowledge in APIs and DPs. | ||||||
| 3 | PQ-3. Collaborate with the experts for collection, interpretation, application and declaration of data in Pharmaceutical Sciences field. | X | |||||
| 4 | PQ-4. Provide best patient counseling services and medication therapy management using his/her knowledge and pharmaceutical information systems to improve the quality of life and safety of patient. | X | |||||
| 5 | PQ-5. Capable of organizing and administering a drugstore as per responsibilities prescribed under the Pharmacy Law, using skills, knowledge and advanced technology systems. | X | |||||
| 6 | PQ-6. Skilfully use computer programs and advanced technology related to the Pharmaceutical Sciences. | X | |||||
| 7 | PQ-7. Provide solutions to the professional issues using scientific knowledge and data. | X | |||||
| 8 | PQ-8. Perform identification, quality control and standardization of the drug products. | ||||||
| 9 | PQ-9. Prepare and implement developmental plans for his/her subordinates, frequently evaluate their progress and make necessary adjustments. | X | |||||
| 10 | PQ-10. Capable of conducting independent studies with his/her advanced knowledge in pharmaceutical sciences, takes responsibilities in professional organizations and efficiently collaborates with the members of his/her own organization as well as other organizations. | X | |||||
| 11 | PQ-11. Clearly show signs of adoption of life-long learning and openness to further development. | X | |||||
| 12 | PQ-12. Critically evaluate their knowledge in pharmaceutical sciences. | X | |||||
| 13 | PQ-13. Closely follow and evaluate the national and international professional developments. | X | |||||
| 14 | PQ-14. Record and document all professional activities and applications. | X | |||||
| 15 | PQ-15. Communicate all necessary information about medicines to patient, medical personnel and public. | ||||||
| 16 | PQ-16. Proficient in English to communicate and follow current knowledge in pharmaceutical sciences. | ||||||
| 17 | PQ-17. Inform officials and organizations about the issues with the quality assurance of pharmaceutical products. | ||||||
| 18 | PQ-18. Actively involve in the preparation of APIs, every stage of the formulation and production of DPs. | ||||||
| 19 | PQ-19. Knowledgable in the regulatory rules of new drug application, data protection and patent issues and understand their interrelationship. | ||||||
| 20 | PQ-20. Have awareness of his/her duties, rights and responsibilities and act based on Pharmacy Law and high professional ethical standards. | X | |||||
| 21 | PQ-21. Familiar with and actively pursue the personal and public health, environmental, and work safety issues. | ||||||
Assessment Methods
| Contribution Level | Absolute Evaluation | |
| Rate of Midterm Exam to Success | 40 | |
| Rate of Final Exam to Success | 60 | |
| Total | 100 | |