|
|
| ECZ4072 | @ | 2+0+0 | ECTS:4 | | Year / Semester | Spring Semester | | Level of Course | Second Cycle | | Status | Elective | | Department | DEPARTMENT of PHARMACEUTICS | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 2 hours of lectures per week | | Lecturer | Dr. Öğr. Üyesi Hatice DEMİRTAŞ | | Co-Lecturer | | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | The primary objective of this course is to train well-equipped students with comprehensive knowledge of pharmaceutical licensing processes within the framework of current regulations, including the preparation of dossiers in Common Technical Document (CTD) format, types of applications, and post-licensing variation management, as well as intellectual and industrial property rights, patent types, and international patent strategies which are of critical importance in the pharmaceutical sector. |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Explains the fundamental concepts related to pharmaceutical licensing processes. | 1 - 2 - 3 - 4 - 5 | 1, | | LO - 2 : | Gains comprehensive knowledge of all modules and sections of the pharmaceutical licensing dossier. | 2 - 3 - 4 | 1, | | LO - 3 : | Gains comprehensive knowledge of patent practices and applications in the pharmaceutical industry. | 2 - 3 - 4 | 1, | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), LO : Learning Outcome | | |
| This course covers the fundamental concepts of drug licensing; the Regulation on Licensing of Medicinal Products for Human Use; documentation requirements for licensing applications; abridged applications and dossier requirements for standard licensing submissions including the Common Technical Document (CTD). Additionally, the course examines the evaluation of applications, rejection, suspension, and revocation of licenses; conditional and exceptional licensing pathways; the validity period of licenses, re-evaluation of licensed products, and types of variations. Furthermore, the curriculum includes specific licensing dossiers and requirements; Intellectual and Industrial Property Rights (IPR); the history of patent protection in Turkey and the world along with international patent treaties; pharmaceutical patent categories, the patent application process, and types of patent licensing. |
| |
| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Purpose, Scope, and General Definitions in Drug Licensing | | | Week 2 | Regulation on the Licensing of Human Medicinal Products | | | Week 3 | Documents Required for Drug Marketing Authorization Applications | | | Week 4 | Abbreviated Application | | | Week 5 | Dossier Requirements for Standard Marketing Authorization Applications and the Common Technical Document (CTD) | | | Week 6 | Evaluation of Marketing Authorization Applications, Rejection of Applications, Suspension, and Revocation of Marketing Authorization | | | Week 7 | Conditional Marketing Authorization and Authorization under Exceptional Circumstances | | | Week 8 | Validity Period of Marketing Authorization, Re-evaluation of Authorized Products, and Types of Variations | | | Week 9 | Midterm Examination | | | Week 10 | Special Marketing Authorization Dossiers and Requirements | | | Week 11 | Intellectual and Industrial Property Rights | | | Week 12 | History of Patent Protection in the World and in Türkiye, and International Agreements on Patents | | | Week 13 | Pharmaceutical Patents and Their Types | | | Week 14 | Patent Application Process | | | Week 15 | Types of Patent Licensing | | | Week 16 | Final Examination | | | |
| 1 | Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği | | | 2 | SINAİ MÜLKİYET KANUNU | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | | 1 | 50 | | End-of-term exam | 16 | | 1 | 50 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 2 | 14 | 28 | | Arasınav | 1 | 1 | 1 | | Dönem sonu sınavı | 1 | 1 | 1 | | Total work load | | | 30 |
|