Course Description
| Course | Code | Semester | T+P (Hour) | Credit | ECTS |
|---|---|---|---|---|---|
| PHARMACEUTICAL REGISTRATION | - | Fall 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 | Elective |
| Course Coordinator | Assist.Prof. Muhammet Davut ARPA |
| Name of Lecturer(s) | Assist.Prof. Muhammet Davut ARPA, Lect.Dr. Duygu YAZICIOĞLU |
| Assistant(s) | |
| Aim | Providing in the subject of drug registration, process and importance of registration, patent, licence types of patents and increasing the potential of studying in these areas for students |
| Course Content | This course contains; 1.Aim, extent and descriptions in drug registration,2.Documents that must be presented in drug registration application.,3.Shortened applications.,4.Derrivated product applications for the registrated active compounds.,5.Returning and rejecting of registration application.,6.Validity period of registration and re-evaluation of registrated products.,7.Drug registration in U.S.A and E.U.,8.Basic terms and patent in drug.,9.History of the protection of patent in Turkey and the World.,10.Non-material and patent ownership rights.,11.Patent in drug.,12.Preparation of patent applications.,13.Licence types of patent.,14.International applications.. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the and of this course, the students will be able to; | ||
| 1.Evaluate registration processes. | 10, 19, 9 | A, E |
| 1.1.Comprehend the aim of registration. | 9 | A |
| 1.2.Describe the document must be included in registration folder. | 10, 9 | A, E |
| 1.3.Classify registration applications. | 10, 19, 9 | A, E |
| 2.Compare national and international condtions of registration. | 10, 16, 9 | A |
| 2.1.Describe the process of registration in European Union. | 9 | A |
| 2.2.Comprehend the conditions of registration in U.S.A. | 9 | A |
| 3.Describe the terms like patent, trademark andindustrial design. | 10, 12, 16, 19, 9 | A, E |
| 3.1.Explains the steps of drug patent. | 9 | A |
| 3.3.Define priority rights and advantages. | 10, 12, 16, 19, 9 | A, E |
| 3.4.Classify types of licence in patent. | 9 | A |
| 3.5.Explains the international agreements associated with patent and trademark. | 9 | A |
| 3.2. Describe the document must be included in patent folder. | 16, 9 | A |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 16: Question - Answer Technique, 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam, E: Homework |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1.Aim, extent and descriptions in drug registration | 1,2 |
| 2 | 2.Documents that must be presented in drug registration application. | 1,2 |
| 3 | 3.Shortened applications. | 1,2 |
| 4 | 4.Derrivated product applications for the registrated active compounds. | 1,2 |
| 5 | 5.Returning and rejecting of registration application. | 1,2 |
| 6 | 6.Validity period of registration and re-evaluation of registrated products. | 1,2 |
| 7 | 7.Drug registration in U.S.A and E.U. | 1,2 |
| 8 | 8.Basic terms and patent in drug. | 1,2 |
| 9 | 9.History of the protection of patent in Turkey and the World. | 1,2 |
| 10 | 10.Non-material and patent ownership rights. | 1,2 |
| 11 | 11.Patent in drug. | 1,2 |
| 12 | 12.Preparation of patent applications. | 1,2 |
| 13 | 13.Licence types of patent. | 1,2 |
| 14 | 14.International applications. | 1,2 |
| Resources |
| 1-The course notes will be given to the students. |
| 2-www.tpe.gov.tr, www.ttb.org.tr, www.uspto.gov, www.epo.org |
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. | ||||||
| 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. | ||||||
| 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. | ||||||
| 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. | ||||||
| 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. | ||||||
| 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 | 0 | 0 | 0 | |||
| Guided Problem Solving | 0 | 0 | 0 | |||
| 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 | 0 | 0 | 0 | |||
| General Exam | 0 | 0 | 0 | |||
| Performance Task, Maintenance Plan | 0 | 0 | 0 | |||
| Total Workload(Hour) | 0 | |||||
| Dersin AKTS Kredisi = Toplam İş Yükü (Saat)/30*=(0/30) | 0 | |||||
| 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 REGISTRATION | - | Fall 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 | Elective |
| Course Coordinator | Assist.Prof. Muhammet Davut ARPA |
| Name of Lecturer(s) | Assist.Prof. Muhammet Davut ARPA, Lect.Dr. Duygu YAZICIOĞLU |
| Assistant(s) | |
| Aim | Providing in the subject of drug registration, process and importance of registration, patent, licence types of patents and increasing the potential of studying in these areas for students |
| Course Content | This course contains; 1.Aim, extent and descriptions in drug registration,2.Documents that must be presented in drug registration application.,3.Shortened applications.,4.Derrivated product applications for the registrated active compounds.,5.Returning and rejecting of registration application.,6.Validity period of registration and re-evaluation of registrated products.,7.Drug registration in U.S.A and E.U.,8.Basic terms and patent in drug.,9.History of the protection of patent in Turkey and the World.,10.Non-material and patent ownership rights.,11.Patent in drug.,12.Preparation of patent applications.,13.Licence types of patent.,14.International applications.. |
| Dersin Öğrenme Kazanımları | Teaching Methods | Assessment Methods |
| At the and of this course, the students will be able to; | ||
| 1.Evaluate registration processes. | 10, 19, 9 | A, E |
| 1.1.Comprehend the aim of registration. | 9 | A |
| 1.2.Describe the document must be included in registration folder. | 10, 9 | A, E |
| 1.3.Classify registration applications. | 10, 19, 9 | A, E |
| 2.Compare national and international condtions of registration. | 10, 16, 9 | A |
| 2.1.Describe the process of registration in European Union. | 9 | A |
| 2.2.Comprehend the conditions of registration in U.S.A. | 9 | A |
| 3.Describe the terms like patent, trademark andindustrial design. | 10, 12, 16, 19, 9 | A, E |
| 3.1.Explains the steps of drug patent. | 9 | A |
| 3.3.Define priority rights and advantages. | 10, 12, 16, 19, 9 | A, E |
| 3.4.Classify types of licence in patent. | 9 | A |
| 3.5.Explains the international agreements associated with patent and trademark. | 9 | A |
| 3.2. Describe the document must be included in patent folder. | 16, 9 | A |
| Teaching Methods: | 10: Discussion Method, 12: Problem Solving Method, 16: Question - Answer Technique, 19: Brainstorming Technique, 9: Lecture Method |
| Assessment Methods: | A: Traditional Written Exam, E: Homework |
Course Outline
| Order | Subjects | Preliminary Work |
|---|---|---|
| 1 | 1.Aim, extent and descriptions in drug registration | 1,2 |
| 2 | 2.Documents that must be presented in drug registration application. | 1,2 |
| 3 | 3.Shortened applications. | 1,2 |
| 4 | 4.Derrivated product applications for the registrated active compounds. | 1,2 |
| 5 | 5.Returning and rejecting of registration application. | 1,2 |
| 6 | 6.Validity period of registration and re-evaluation of registrated products. | 1,2 |
| 7 | 7.Drug registration in U.S.A and E.U. | 1,2 |
| 8 | 8.Basic terms and patent in drug. | 1,2 |
| 9 | 9.History of the protection of patent in Turkey and the World. | 1,2 |
| 10 | 10.Non-material and patent ownership rights. | 1,2 |
| 11 | 11.Patent in drug. | 1,2 |
| 12 | 12.Preparation of patent applications. | 1,2 |
| 13 | 13.Licence types of patent. | 1,2 |
| 14 | 14.International applications. | 1,2 |
| Resources |
| 1-The course notes will be given to the students. |
| 2-www.tpe.gov.tr, www.ttb.org.tr, www.uspto.gov, www.epo.org |
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. | ||||||
| 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. | ||||||
| 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. | ||||||
| 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. | ||||||
| 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. | ||||||
| 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 | |