FDALR_FAF Regulatory Affairs

Faculty of Pharmacy
Autumn 2023
Extent and Intensity
1/1/0. 25 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
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
They are listed in the section on learning outcomes.
Learning outcomes
After completing this subject, students should be well oriented in the field of creating, evaluating and updating documentation related to drug regulation, or they should be able to actively intervene in the processes in the field of harmonization. Attention is paid to the means of preventing the entry of counterfeit medicines into the market due to the timeliness of this measure.
Syllabus
  • Regulatory Affairs
    The aim of the course is to extend the knowledge of students in the fields of registration documentation creation, registration procedures and post-authorization drug monitoring.
    A great attention is paid to the Regulatory Intelligence.
    The key theme of this subject is the harmonization of standards and regulations to ensure the safety, efficacy and quality of medicines.
    In this context a large space is dedicated to the issue of counterfeit medicines and to so called the FMD (Falsified Medicines Directive).
    The role of regulators in this area with respect to the EU and the US is discussed and compared.
Literature
    required literature
  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). URL URL info
  • Zákon č. 378/2007 Sb., o léčivech a o změnách některých souvisejících zákonů (zákon o léčivech). info
    recommended literature
  • EudraLex ? Volume 1 ? Pharmaceutical legislation for medicinal products for human use. URL info
  • Official Journal of the European Union: COMMISSION DELEGATED REGULATION (EU) 2016/161. info
  • Vyhláška č. 228/2008 Sb., o registraci léčivých přípravků. info
Teaching methods
Teaching is based on consultations and independent 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
Exam - oral exam (on-site/on-line - in accordance with the current epidemiological situaion).
Language of instruction
Czech
Further Comments
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, Autumn 2021, Spring 2022, Autumn 2022, Spring 2023, Spring 2024, Autumn 2024, Spring 2025.
  • Enrolment Statistics (Autumn 2023, recent)
  • Permalink: https://is.muni.cz/course/pharm/autumn2023/FDALR_FAF