F1RL1_11 Marketing Authorisation of Pharmaceuticals

Faculty of Pharmacy
Spring 2021
Extent and Intensity
1/0/0. 2 credit(s). Type of Completion: z (credit).
Teacher(s)
doc. Ing. Jiří Dohnal, CSc., MBA (lecturer)
Guaranteed by
doc. Ing. Jiří Dohnal, CSc., MBA
Department of Applied Pharmacy – Departments – Faculty of Pharmacy
Supplier department: Department of Applied Pharmacy – Departments – Faculty of Pharmacy
Timetable
Mon 17. 5. 9:00–12:00 45-221, 13:00–16:45 45-221, Tue 18. 5. 9:00–12:00 45-135
Prerequisites
a
Course Enrolment Limitations
The course is also offered to the students of the fields other than those the course is directly associated with.
The capacity limit for the course is 100 student(s).
Current registration and enrolment status: enrolled: 2/100, only registered: 0/100, only registered with preference (fields directly associated with the programme): 0/100
fields of study / plans the course is directly associated with
Course objectives
Students will acquire knowledge of the global pharmaceutical registration system, with special attention to the Czech Republic, European Union and regions such as Euroasia, LATAM, MENA and APAC.
Learning outcomes
After completing the course, the student will be able to: - understand the function of the registration department of global and domestic pharmaceutical companies; - understand the different requirements for registration dossiers in different territories; - understand the need to apply the latest scientific knowledge in the creation of registration dossiers and in the process of Regulatory Intelligence; - identify the possibility of his/her own work in the Regulatory Affairs departments of global and domestic pharmaceutical companies;
Syllabus
  • Lectures are divided into two teaching blocks: 1st block Introduction to the subject 1a) Global Pharmaceutical Registration System 1b) Development and research of drugs 1c) SÚKL and its activities 1d) Role and strategic importance of registrations 1e) Biological preparations, biosimilars and preparations of modern therapy 1f) Registration in the Czech Republic & EU 1g) Regulatory Intelligence 2nd block 2a) Eurasia & LATAM registration 2b) OTC products and registration strategies 2c) MENA & APAC registration 2d) Proof of origin and protection against "faked drugs" 2e) Post-marketing activities of the marketing authorization holder Test - case study Q&A End
Literature
    recommended literature
  • Gonsior, O., Kolář, J. Registrace léčivých přípravků: II. Originální přípravky (skripta VFU). Brno, 2017. info
  • Černíčková, Z., Kolář, J. Registrace léčivých přípravků: I. Generické přípravky (skripta VFU). Brno, 2016. info
Teaching methods
Lectures; presentations by professionals in the sectors; class discussion
Assessment methods
Min. 80% attendance at classes. Questionnaire; credits
Language of instruction
Czech
Further Comments
Study Materials
The course can also be completed outside the examination period.
The course is also listed under the following terms Spring 2020, Spring 2022, Spring 2023, Spring 2024, Spring 2025.
  • Enrolment Statistics (Spring 2021, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2021/F1RL1_11