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| ECZ5015 | Biomedical Products and Devices | 2+0+0 | ECTS:4 | | Year / Semester | Fall 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 Serhat SEVGİ | | Co-Lecturer | Prof. Dr. F. Sena Sezen | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | The aim is to teach the legal processes, national/international legislation and institutions/organizations in the classification, development and licensing of biomedical products and devices; to teach the life cycle of new medical devices, including preclinical and clinical research processes before and after their launch on the market, vigilance studies and the role and responsibilities of the pharmacist in all these processes; and to interpret examples of current scientific studies in the relevant field. |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Understands the concepts, scope, and current classification of biomedical products, medical devices, and in vitro diagnostic medical devices. | 1 - 2 - 6 | 1, | | LO - 2 : | Knows the organizations responsible for current national and international legal regulations related to biomedical products and medical devices, and can keep up-to-date on relevant information and developments. | 1 - 2 - 6 | 1, | | LO - 3 : | Defines the roles of all institutions and organizations in the life cycle of biomedical products and medical devices (from preclinical research to licensed product commercialization, including ethics committee work), and the roles and responsibilities of pharmacists in these processes. | 1 - 2 - 6 | 1, | | LO - 4 : | Knows the vigilance studies related to the notification and reporting of adverse events related to biomedical products and medical devices, the principles of these studies, and the role of the pharmacist. | 1 - 2 - 6 | 1, | | LO - 5 : | Understands, evaluates, and presents current scientific publications on biomedical products and devices. | 1 - 2 - 6 | 1,5, | | 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 concepts, classifications, and relevant legal regulations of medical devices and in vitro diagnostic medical devices. The implementation of the Turkish Medicines and Medical Devices Agency (TİTCK), the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), and the Organization for Economic Co-operation and Development (OECD) within the framework of national and international legislation related to pharmaceuticals and medical devices is examined. Information is provided on preclinical and clinical research processes for medical devices, conformity assessment procedures, and quality management systems. Throughout the course, the roles and responsibilities of industry representatives and the potential contributions of pharmacists in these processes are discussed. Furthermore, the learning process is supported by the assessment of external stakeholder views (e.g., pharmacists working in public hospitals), field visits/technical trips, and student presentations of articles on medical devices. |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | General information, definitions and classifications of biomedical products and devices-1 | | | Week 2 | General information, definitions and classifications of biomedical products and devices-2 | | | Week 3 | Emergence of legal regulations and recent developments regarding biomedical products and devices | | | Week 4 | National and international organizations responsible for legal regulations regarding biomedical products and devices | | | Week 5 | National and international legislation regarding biomedical products and devices | | | Week 6 | Clinical research and conformity assessment activities in biomedical products and devices | | | Week 7 | Life cycle of biomedical products and devices and obligations of economic operators | | | Week 8 | The Role of Medical Device Industry Representatives and Healthcare Managers in Medical Device Procurement Processes (External Stakeholder Guest Pharmacist) | | | Week 9 | mid term exam | | | Week 10 | Student Group1 - article presentation on biomedical products | | | Week 11 | Student Group2 - article presentation on biomedical products | | | Week 12 | Student Group3 - article presentation on biomedical products | | | Week 13 | Student Group4 - article presentation on biomedical products | | | Week 14 | Student Group5-6 - article presentation on biomedical products | | | Week 15 | Field visit/Technical tour | | | Week 16 | final examination | | | |
| 1 | Balçık, P. Y., Kartal, N., & Konca, M. (2019). İlaç ve Tıbbi Cihaz Endüstrisi ve Yerelleşme (1. baskı). Ankara: Nobel Yayıncılık. | | | 2 | Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK). Resmî web sitesi. Erişim adresi: http://www.titck.gov.tr/ | | | |
| 1 | World Health Organization (WHO). Medical devices ? Assistive and medical technology. Erişim adresi: https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices | | | 2 | European Medicines Agency (EMA). Human regulatory overview ? Medical devices. Erişim adresi: https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices | | | 3 | U.S. Food & Drug Administration (FDA). Medical Devices. Erişim adresi: https://www.fda.gov/medical-devices | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | | | 50 | | Presentation | 10-15 | | | 25 | | End-of-term exam | 16 | | | 25 | | |
| 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 için hazırlık | 3 | 8 | 24 | | Arasınav | 1 | 1 | 1 | | Dönem sonu sınavı için hazırlık | 3 | 6 | 18 | | Dönem sonu sınavı | 1 | 1 | 1 | | Diğer 1 | 5 | 6 | 30 | | Total work load | | | 102 |
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