FDAFV_FAF Pharmacovigilance

Faculty of Pharmacy
Autumn 2021
Extent and Intensity
1/1/0. 25 credit(s). Type of Completion: zk (examination).
Teacher(s)
PharmDr. Bc. Hana Kotolová, Ph.D. (lecturer)
Guaranteed by
PharmDr. Bc. Hana Kotolová, Ph.D.
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
Pharmacovigilance has been defined by the World Health Organisation as ?The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem?.
Learning outcomes
The student will gain a more detailed look at the issue of pharmacovigilance.
Syllabus
  • Introduction to the study of the definition of pharmacovigilance, the clinical development of the medicinal product.
    Basic concepts in pharmacovigilance.
    Side effect, adverse event.
    Types of side effects.
    The types of adverse events.
    Pharmacotherapeutic risk.
    Drug-drug interactions-pharmacokinetic, pharmacodynamic.
    The clinical presentation of adverse reactions to drugs.
    System for reporting, types of reports.
    Legislation in the field of pharmacovigilance.
Literature
    required literature
  • Demlová Regina, Říhová Barbora, Grycová Zuzana, Nerušilová Kateř. Životní cyklus léčiv. MASARYKOVA UNIVERZITA LÉKAŘSKÁ FAKULTA, 2014. URL info
  • Vršková D., Pistovčáková J., Landa L. Farmakovigilance a propagace léčiv. MASARYKOVA UNIVERZITA LÉKAŘSKÁ FAKULTA, 2007. URL info
    recommended literature
  • Švihovec Jan a kolektiv. Farmakologie. Grada, Praha, 2018. ISBN 978-80-247-5558-8. URL info
  • Starobová O., Landa L., Nováková J., Šulcová A. VÝZKUM NOVÝCH LÉČIV od zrodu k registraci. MASARYKOVA UNIVERZITA LÉKAŘSKÁ FAKULTA, 2006. URL info
Teaching methods
Individual consultations, methods of working with text (textbook, book, professional articles).
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.
The course is also listed under the following terms Spring 2020, Autumn 2020, Spring 2021, Spring 2022, Autumn 2022, Spring 2023, Autumn 2023, Spring 2024, Autumn 2024, Spring 2025.
  • Enrolment Statistics (Autumn 2021, recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2021/FDAFV_FAF