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| ECZ5037 | Clinical Trials and the Role of Pharmacist | 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 Yeşim KAYA YAŞAR | | Co-Lecturer | Dr. Mefkure Durmuş | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | Teaching the pre-clinical process of novel drug research, clinical drug research, ethics committees and pharmacovigilance studies in clinical drug research and the role of pharmacist |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Defines pre-clinical processes in novel drug research | | | | LO - 2 : | Defines clinical trial periods in drug development | | | | LO - 3 : | Knows the ethical aspects of clinical drug research | | | | LO - 4 : | Knows the provisions of the regulations related to ethics committees and their work. | | | | LO - 5 : | Knows pharmacovigilance studies in clinical drug trials. | | | | LO - 6 : | Defines the duties and responsibilities of the pharmacist in clinical drug research. | | | | 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 | | |
| Pre-clinical process of novel drug research, clinical drug research (Phase I-IV), ethics committees, regulations related to clinical drug research, pharmacovigilance practices in clinical drug research and the role of pharmacist |
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