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SEC593 DRUG SAFETY SURVEILLANCE.doc

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SEC593 DRUG SAFETY SURVEILLANCE.doc

  1. 1. SEC…Eng 1 HACETTEPE UNIVERSITY ELECTIVE COURSES UNIT COORDINATORSHIP Course Information Course Name Code Semester Theory (hours/week) Application (hours/week) Laboratory (hours/week) National Credit ECTS DRUG SAFETY SURVEILLANCE SEC 593 Fall/ Spring 2 0 0 2 4 Prerequisites To be student in Faculty of Medicine Course language TURKISH Course type ELECTIVE Learning and teaching strategies ORAL PRESENTATIONS (LECTURES) Instructor (s) PROF.TERKEN BAYDAR, PhD – PHARM. DEMET AYDINKARAHALİLOĞLU, PhD Course objective RAISING AWARENESS IN STUDENTS OF HACETTEPE UNIVERSITY FACULTY OF MEDICINE AND EFFICIENT DRUG TREATMENT WITH CAUSALITY EVALUATION. Learning outcomes ENHANCING THE BASIC INFORMATION LEVEL OF SAFE USE OF DRUGS IN HACETTEPE STUDENTS AND THE STUDENTS WHO WILL BE A PART OF HEALTHCARE SYSTEM. Course Content SYSTEMATICALLY INFORMING STUDENTS ON ADVERSE DRUG REACTIONS AND THEIR BENEFIT/RISK BALANCES IN ORDER TO IMPLEMENT SAFE DRUG USE, ADVERSE DRUG REACTIONS RESULTING FROM THERAPEUTIC DOSAGES AND THEIR EXAMPLES, ALSO TEACHING BASIC PREDICTIONS ON THE USE OF DRUGS AND TRAINING TO BE USED FOR SAFE DRUG CONSUMPTION BY RISK EVALUATION STAGES. References 1. TOKSİKOLOJİNİN TEMELLERİ (Curtis D. Klaassen John B. Watkins), S. Süzen, P. Erkekoğlu, A. O. Ada, O. Erdem, G. Çakmak Demircigil, B. Demirel, ANKARA NOBEL TIP KİTABEVİ, ANKARA, 2017. 2. FARMASÖTİK TOKSİKOLOJİ (Gerard J. Mulder, Lennart Dencker) Çeviri Kitap, N. Başaran, T. Baydar, Ü. Ündeğer Bucurgat, B. Koçer Giray, A. Gürbay, H. Özgüneş, G. Şahin, NOBEL TIP KİTABEVLERİ, ISBN 9789754209679, ANKARA, 2013. 3. Sağlık Bakanlığı Türkiye İlaç ve Tıbbi Cihaz Kurumu, Available address: http://www.titck.gov.tr/Ilac/Farmakovijilans Available date: May 21, 2018. 4. N. D. Aydınkarahaliloğlu & S. O. Kayaalp, Farmakovijilans, in KLİNİK FARMAKOLOJİNİN ESASLARI VE TEMEL DÜZENLEMELER, Kayaalp O (ed), 5th Edition, 309-370, 2013. Weekly Course Outline Weeks Topics 1. BASIC PRINCIPLES AND DEFINITIONS IN PHARMACEUTICAL SAFETY MONITORING 2. MONITORING THE SAFETY OF DRUGS AFTER LICENSING - EXPERIENCES 3. PHARMACOVIGILANCE AND TYPES OF ADVERSE DRUG REACTIONS 4. GENETIC SETTINGS OF ADVERSE DRUG REACTIONS
  2. 2. SEC…Eng 2 5. RESPONSIBLE PARTIES ON ADVERSE DRUG REACTION REPORTING, NOTIFICATION FORM AND RAISING AWARENESS IN THIS SUBJECT 6. CASE STUDIES-CURRENT EXPERIENCES 7. ALGORITHMS USED IN CERTAIN DRUG SAFETY EVALUATION 8. PROTECTION OF PERSONAL RIGHTS AND CONFIDENTIALITY OF THE DATA IN PHARMACOVIGILANCE PERSPECTIVE 9. PHARMACOVIGILANCE ACTIVITIES IN TURKEY AND THE WORLD 10. PHARMACOEPIDEMIOLOGICAL STUDIES 11. SIGNAL DETECTION IN PHARMACOVIGILANCE 12. MATHEMATICAL METHODS USED IN BENEFIT / RISK ASSESSMENT I 13. MATHEMATICAL METHODS USED IN BENEFIT / RISK ASSESSMENT II 14. RISK MANAGEMENT PLAN AND RISK COMMUNICATION 15. FEED-BACKS AND RECOVERY ABOUT COURSE Assessment Methods Course Activities Number Percentage Attendance Laboratory Application Field activities Specific practical training Assignments Presentation Project Seminar Midterms 1 50 % Final exam 1 50 % Total 2 100 Percentage of semester activities contributing grade succes 50 % Percentage of final exam contributing grade succes 50 % Total 100 % Workload and ECTS Calculation Activities Number Duration (Hour) Total Work Load Course Duration (x14) 14 2 28 Laboratory - - - Application - - - Specific practical training - - - Field activities - - - Study Hours Out of Class (Preliminary work, reinforcement, ect) 12 3 36 Presentation / Seminar Preparation - - - Project - - - Home assignment - - - Midterms ( Study duration ) 1 25 25 Final Exam (Study duration) 1 31 31 Total Work Load ECTS 120 Hours

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