| Pharmacy (English) | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
| Course Code: | PHA029 | ||||
| Course Name: | Licensing and Patent in Pharmaceuticals | ||||
| Semester: | Fall | ||||
| Course Credits: |
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| Language of instruction: | |||||
| Course Condition: | |||||
| Does the Course Require Work Experience?: | No | ||||
| Type of course: | Departmental Elective | ||||
| Course Level: |
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| Mode of Delivery: | Face to face | ||||
| Course Coordinator: | Prof. Dr. SEMRA ŞARDAŞ | ||||
| Course Lecturer(s): | PROF. DR. SEMRA ŞARDAŞ | ||||
| Course Assistants: |
| Course Objectives: | Comparison of licenses of different types of products. Local and international evaluation of legislation and regulations. To learn the necessary criteria for the preparation of the license dossier. Knowledge of file requirements and processes. Examining the patent types, learning how to do patent scans and having information about the application processes |
| Course Content: | License types of drugs and medicinal products. Examination of relevant regulations and legislation. Drug development processes and characterization of ingredients. Quality control parameters and required tests and analyzes. Requirements for the preparation of license dossiers. Examining patent types, scans and application processes. |
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The students who have succeeded in this course;
1) Knows the differences in certification of medicinal products. 2) Knows how to follow national and international legislation. 3) Has an idea about the criteria to be included in the licensing files. 4) Knows the general differences of licensing files. 5) Has an idea about patent types, patent scanning, patent process and property rights. |
| Week | Subject | Related Preparation |
| 1) | What is a License, How to License a Drug | |
| 2) | Licensing and Permission | |
| 3) | License Process Flow Chart | |
| 4) | Module 1: Regional Administrative Information ve Module 2: Quality Information, Non-Clinical and Clinical Summaries | |
| 5) | Module 3: Quality | |
| 6) | Module 4: Non-Clinical Study Reports | |
| 7) | Module 5: Clinical Study Reports | |
| 8) | Midterm Exam and Application types, Licensing Regulation / Legislation | |
| 9) | Forms | |
| 10) | SmPC (Summary of Product Characteristics) / PT (Patient Leaflet) | |
| 11) | Licensing Specialist | |
| 12) | Patent in Pharmaceuticals and Medical Products | |
| 13) | Patent application and protection | |
| 13) | Patent application and protection | |
| 14) | Case study on patents | |
| 15) | Final Exam Period |
| Course Notes / Textbooks: | ICH YÖNETMELİKLER |
| References: | TİTCK YÖNETMELİK VE KILAVUZLARI |
| Course Learning Outcomes | 1 |
2 |
3 |
4 |
5 |
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| Program Outcomes | |||||||||||
| 1) Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 3 | 3 | 3 | 3 | 3 | ||||||
| 2) Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 3 | 3 | 3 | 3 | 3 | ||||||
| 3) Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | |||||||||||
| 4) Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | |||||||||||
| 5) Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |||||||||||
| 6) Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | |||||||||||
| 7) Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | |||||||||||
| 8) He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | 3 | 3 | 3 | 3 | 3 | ||||||
| 9) Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | 2 | 2 | 2 | 2 | 2 | ||||||
| 10) As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 | 3 | 3 | 3 | 3 | ||||||
| 11) He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 | 3 | 3 | 3 | 3 | ||||||
| No Effect | 1 Lowest | 2 Average | 3 Highest |
| Program Outcomes | Level of Contribution | |
| 1) | Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 3 |
| 2) | Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 3 |
| 3) | Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | |
| 4) | Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | |
| 5) | Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |
| 6) | Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | |
| 7) | Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | |
| 8) | He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | 3 |
| 9) | Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | 2 |
| 10) | As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 |
| 11) | He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 |
| Semester Requirements | Number of Activities | Level of Contribution |
| Midterms | 1 | % 30 |
| Final | 1 | % 70 |
| total | % 100 | |
| PERCENTAGE OF SEMESTER WORK | % 30 | |
| PERCENTAGE OF FINAL WORK | % 70 | |
| total | % 100 | |
| Activities | Number of Activities | Workload |
| Course Hours | 14 | 28 |
| Study Hours Out of Class | 14 | 53 |
| Midterms | 1 | 2 |
| Final | 1 | 2 |
| Total Workload | 85 | |