FDALR_FAF Regulatory Affairs

Faculty of Pharmacy
Spring 2020
Extent and Intensity
1/1/0. 25 credit(s). Type of Completion: zk (examination).
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
Abstract
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.
Key topics
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.
Study resources and 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
Approaches, practices, and methods used in teaching (in Czech)
Dialogická (diskuze, rozhovor, brainstorming)
Metody práce s textem (učebnicí, knihou)
Method of verifying learning outcomes and course completion requirements (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 25
Domácí příprava na výuku 25
Summary 50
The course is also listed under the following terms Autumn 2020, Spring 2021, Autumn 2021, Spring 2022, Autumn 2022, Spring 2023, Autumn 2023, Spring 2024, Autumn 2024, Spring 2025.
  • Enrolment Statistics (Spring 2020, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2020/FDALR_FAF