FaF:FDABL_FAF Safety and Quality of Drugs - Course Information

FDABL_FAF Safety and Quality of Drugs

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

• Safety and Quality of Drugs (programme FaF, D-BKL) (2)

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

Given that the Safety and Quality of Medicines is an applied interdisciplinary field focused on the care of the health of the population in terms of ensuring the quality, safety and efficacy of medicinal products, medical devices and food supplements will provide students with a broad overview in these areas as an extension of the master's field.

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.

• Enrolment Statistics (Spring 2025, recent)
  
• Permalink: https://is.muni.cz/course/pharm/spring2025/FDABL_FAF