Код: 296317

Назва:

Клінічні дослідження та фармацевтичний менеджмент

Анотація: Course "Клінічні дослідження та фармацевтичний менеджмент / Clinical trials and pharmaceutical management (англ. мовою)" is a practical guide to navigate through the processes behind the development and postmarketing surveillance of drugs and medical devices. It is a brief introduction into the industry, encompassing legal, ethical, methodological, and practical limitations and opportunities of creating, investigating, and moving medicinal products and devices to the market.

Тип дисципліни: selective professional orientation

Рік навчання: 2

Семестр: spring

Кількість кредитів: 3 (total hours - 90; classes - 45; individual learning - 45)

Форма контролю: exam

Викладач(і): senior lecturer Mariia Yashchenko

Результати навчання: As a result of studying the discipline, the student should be able to:
" understand difference between clinical trials and other types of studies with human subjects;
" distinguish between different stages of clinical development of drugs and medical devices,
" understand the pipeline of drugs and medical devices development from concept to postmarketing surveillance,
" understand the roles involved into clinical trials,
" know the skills to be developed for each of the entry-level positions in clinical trials
" know and understand legal and ethical constraints of clinical trials
" be able to assess if the presented results of the clinical trial are methodologically correct and scientifically sound.



Спосіб навчання: classes

Необхідні обовязкові попередні й супутні модулі: -

Зміст дисципліни: Course is set towards understanding of the clinical trials methodology, phases of development, pre- and postmarketing processes of the medicinal products and devices. The course describes the roles of different stakeholders in clinical trials, with emphasis on the entry roles. During the course the student will learn, which processes are vital for clinical trials to succeed: biometrics, clinical operations, data management components. It is designed to let students detect the true and deceiving data derived from clinical trials, determine ethical, legal, and practical issues to be overcame prior to the product marketing.


Рекомендована література: 1 December 2016 EMA/CHMP/ICH/135/1995 Committee for Human Medicinal Products Guideline for good clinical practice E6(R2) Step 5
Friedman, Lawrence & Furberg, Curt & DeMets, David & Reboussin, David & Granger, Christopher. (2015). Fundamentals of Clinical Trials. 10.1007/978-3-319-18539-2.
International Standards for Clinical Trial Registries - Version 3.0.Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO.


Форми та методи навчання: lectures, seminars, individual learning

Методи й критерії оцінювання: 100-point rating: formative assessment - 70 points (survey, participation in classes, individual performance); summative (final control) - 30 points (credit, exam).

Мова навчання: English