FDFV1_FAF Pharmacovigilance

Faculty of Pharmacy
Spring 2026
Extent and Intensity
2/0. 5 credit(s). Type of Completion: zk (examination).
In-person direct teaching
Teacher(s)
PharmDr. Bc. Hana Kotolová, Ph.D. (lecturer)
Guaranteed by
PharmDr. Bc. Hana Kotolová, Ph.D.
Faculty of Pharmacy
Supplier department: Department of Pharmacology and Toxicology – Departments – Faculty of Pharmacy
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
Abstract
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.
Key topics
Introduction to the study, definition of pharmacovigilance, the clinical development of the medicinal product.
Basic concepts in pharmacovigilance.
Side effect, adverse event.
Types of side effects.
Types of adverse events.
Pharmacotherapeutic risk.
Drug-drug interactions - pharmacokinetic, pharmacodynamic.
The clinical manifestation of adverse reactions to drugs.
System for reporting, types of reports.
Legislation in the field of pharmacovigilance.
Study resources and literature
    required literature
  • Demlová Regina, Říhová Barbora, Grycová Zuzana, Nerušilová Kateř. Životní cyklus léčiv. MASARYKOVA UNIVERZITA LÉKAŘSKÁ FAKULTA, 2014. URL info
  • WALLER, Patrick and Mira HARRISON-WOOLRYCH. An introduction to pharmacovigilance. Second edition. Chichester: Wiley Blackwell, 2017, 1 online. ISBN 9781119289784. URL info
    recommended literature
  • BROWN, M. J.; Pankaj SHARMA; Fraz A. MIR and P. N. BENNETT. Clinical pharmacology. Twelfth edition. Edinburgh: Elsevier, 2019, 1 online. ISBN 9780702073304. URL info
  • Švihovec Jan a kolektiv. Farmakologie. Grada, Praha, 2018. ISBN 978-80-247-5558-8. URL info
Approaches, practices, and methods used in teaching
Individual consultations, methods of working with text (textbook, book, professional articles).
Method of verifying learning outcomes and course completion requirements
Oral exam.
Alternate completion
It is possible to take the oral exam after returning from the internship abroad.
Language of instruction
Czech
Teacher's information
The Ph.D. study program in Pharmacy is conducted in the Czech language, but the subject may be taught in English, depending on the student's language preferences. Study literature and scientific literature are also available in English.
The course is also listed under the following terms Spring 2025, Autumn 2025.
  • Enrolment Statistics (recent)
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