FDABL_FAF Safety and Quality of Drugs

Faculty of Pharmacy
Autumn 2020
Extent and Intensity
1/1/0. 30 credit(s). Type of Completion: zk (examination).
Teacher(s)
doc. Ing. Jiří Dohnal, CSc., MBA (lecturer)
PharmDr. Karel Vašut, Ph.D. (lecturer)
prof. MUDr. Jiří Vítovec, CSc. (lecturer)
Guaranteed by
doc. Ing. Jiří Dohnal, CSc., MBA
Faculty of Pharmacy
Prerequisites (in Czech)
FAKULTA(FaF)
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.
fields of study / plans the course is directly associated with
Course objectives
To provide students with a range of knowledge and insights, such as extending Master's degree program in Safety and Quality of Medicines to improve quality control of medicines, medical devices and food supplements, and to improve patient care.
Learning outcomes
After completing the course, the student will be able to: - understand and actively use the latest means and methods to ensure the safety and quality of medicines; - to orientate in the control and monitoring system in pharmacy and medicine and to actively participate in their use and creation; - use harmonized standards and regulations and actively participate in their evaluation and development
Syllabus
  • Safety and quality of pharmaceuticals
    The safety and quality of pharmaceuticals is an applied interdisciplinary field, oriented to the health care of the population in terms of quality assurance, safety and efficacy of medicinal products, medical devices and food supplements. It is a complex of professional and scientific procedures and international and ethical standards which, on the basis of a broad interdisciplinary cooperation, enable the effective application of knowledge in quality care for the population.
    The subject combines not only the knowledge of all pharmaceutical disciplines, but also medical (theoretical and clinical), biological, chemical, technical and social sciences. It is a part of the control and monitoring system in pharmacy and medicine, which is a subsystem of the superior health system, also combines health, medical, pharmaceutical sciences in practice. All in order to improve the system of quality control and patient care.

Literature
    required literature
  • EudraLex ? Volume 1 ? Pharmaceutical legislation for medicinal products for human use. URL info
    recommended literature
  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). URL URL info
  • The EDQM Pharmaceutical care quality indicators project. EDQM, 2017. info
  • Pharmaceutical Care - Policies and practices for a safer, more responsible and cost-effective health system. EDQM, 2012. info
  • Evens, Ronald (Ed.). Drug and Biological Development. 2007. ISBN 978-0-387-69094-0. info
    not specified
  • Bouwman, Yvonne, Fenton-May, V'Iain, Le Brun, Paul (Eds.). Practical Pharmaceutics. Springer, 2015. ISBN 978-3-319-15814-3. info
Teaching methods
Teaching is based on consultations and self preparation for the exam. Contact with the teacher is via e-mail and in the form of direct consultations. The system of consultations is individually determined according to the time possibilities of the student and the academic staff member. From the point of view of its monitoring, the study includes an introductory consultation on the subject, consultations related to the professional focus of the student's dissertation and preparation for the exam, assessment of the study result by oral exam.
Assessment methods
Oral exam.
Language of instruction
Czech
Further comments (probably available only in Czech)
The course can also be completed outside the examination period.
The course is taught each semester.
Teacher's information
Teaching takes place through personal consultations and other educational activities recommended by the guarantor of the subject.
The course is also listed under the following terms Spring 2020, Spring 2021, Autumn 2021, Spring 2022, Autumn 2022, Spring 2023, Autumn 2023, Spring 2024, Autumn 2024, Spring 2025.
  • Enrolment Statistics (Autumn 2020, recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2020/FDABL_FAF