TÜRKÇE
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Information
| Unit | FACULTY OF PHARMACY |
| PHARMACY PR. | |
| Code | ECS540 |
| Name | Patent and Drug Licensing in Pharmacy |
| Term | 2020-2021 Academic Year |
| Semester | 10. Semester |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 3 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Belirsiz |
| Type | Normal |
| Label | E Elective |
| Mode of study | Uzaktan Öğretim |
| Catalog Information Coordinator | Dr. Öğr. Üyesi ESRA DEMİRTÜRK |
| Course Instructor |
Dr. Öğr. Üyesi ESRA DEMİRTÜRK
(Bahar)
(A Group)
(Ins. in Charge)
Doç. Dr. UMAY MERVE GÜVEN BÖLGEN (Bahar) (A Group) (Asst. Ins.) |
Course Goal / Objective
Inventions in the world and Turkey, patents, intellectual property rights, drug development, clinical research, examining the process from the licensing and marketing and cultivating people who have information on these topics
Course Content
Drug research in the world and Turkey, patents, innovation, state and industry applicability of the art, patent types in the pharmaceutical field, how to patent screening, development with a drug different methods, evaluation of the formulation and clinical trials, manufacturing techniques, how the drug application investigation
Course Precondition
Resources
Notes
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Have knowledge about the basic information about intellectual property, inventions in Turkey and the World |
| LO02 | Explain the principles, know how to submit patent application, evaluate existing patents |
| LO03 | Have knowledge about drug development, formulation, evaluation of clinical studies, production techniques, quality control and quality assurance systems, explain basic principles about the them, |
| LO04 | Knows how to make a drug authorization application and how the health authorities evaluate that file. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | - | Have sufficient knowledge in pharmaceutical field and develop the knowledge gained. | |
| PLO02 | - | Applies the profession in accordance with the existing laws and regulations,gains awareness of professional and ethical responsibility. | |
| PLO03 | - | It serves the society as a pharmacist who is loyal to Atatürk's principles and reforms, equipped with Universal Knowledge, who uses Turkish correctly and knows at least one foreign language. | |
| PLO04 | - | Communicates effectively both orally and in writing. | |
| PLO05 | - | External appearance, attitude, attitude and behavior, with professional identity, role model and society becomes an example to colleagues. | |
| PLO06 | - | Provides consultancy services to patients, community and health care personnel with a wide range of information on the drug,evaluates advanced knowledge and skills with a critical approach. | |
| PLO07 | - | Possessing the knowledge of historical and current developments in the field of Pharmacy, monitoring, evaluation and application of scientific and evidence-based data, and adopting lifelong learning. | |
| PLO08 | - | Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. | |
| PLO09 | - | Interprets information about current health and treatment problems. Plays an active role in community health. | |
| PLO10 | - | Pharmacy integrates and develops professional knowledge with information from different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community. | |
| PLO11 | - | Students will be able to use the concepts and applications of basic sciences and basic medical sciences effectively in the field of Medicine and pharmacy and have the experience of working with these health sciences. | |
| PLO12 | - | Acquires basic information about diseases, adopts and applies rational drug use on all drugs that affect systems. | |
| PLO13 | - | By learning the basics of Clinical Pharmacy,will have the knowledge and skills to help provide drug/patient oriented pharmacy applications and individualized Pharmaceutical Care. | |
| PLO14 | - | It plays a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Patent and patent system in pharmaceutical industry | Lecture, Discussion, Written exam | |
| 2 | Novelty, inventive step, industrial application | Lecture, Discussion, Written exam | |
| 3 | Innovation and types of innovations | Lecture, Discussion, Written exam | |
| 4 | Patent search | Lecture, Discussion, Written exam | |
| 5 | Patent writing | Lecture, Discussion, Written exam | |
| 6 | Patent application methods | Lecture, Discussion, Written exam | |
| 7 | Evaluation of registration dossier in regard to biavailability and bioequivalence | Lecture, Discussion, Written exam | |
| 8 | Mid-Term Exam | ||
| 9 | Registration applications in the World I | Lecture, Discussion, Written exam | |
| 10 | Registration applications in the World II | Lecture, Discussion, Written exam | |
| 11 | Registration of blood products | Lecture, Discussion, Written exam | |
| 12 | Registration of medical devices | Lecture, Discussion, Written exam | |
| 13 | In vivo evaluations in registrations | Lecture, Discussion, Written exam | |
| 14 | Registration of biotechnological products | Lecture, Discussion, Written exam | |
| 15 | Registration of vaccines | Lecture, Discussion, Written exam | |
| 16 | Term Exams | ||
| 17 | Term Exams |