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)

Guaranteed by

doc. Ing. Jiří Dohnal, CSc., MBA
Faculty of Pharmacy

Course Enrolment Limitations

The course is also offered to the students of the fields other than those 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.

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 (in Czech)

Dialogická (diskuze, rozhovor, brainstorming)
Metody práce s textem (učebnicí, knihou)

Assessment methods (in Czech)

Ústní zkouška

Language of instruction

Czech

Further comments (probably available only in Czech)

The course can also be completed outside the examination period.

Teacher's information

Teaching takes place through personal consultations and other educational activities recommended by the guarantor of the subject.

Activity	Difficulty [h]
Domácí příprava na výuku	30
Domácí příprava na výuku	30
Summary	60

• Enrolment Statistics (Spring 2020, recent)
  
• Permalink: https://is.muni.cz/course/pharm/spring2020/FDABL_FAF