FaF:F1RL1_11 Registration of Pharmaceutical - Course Information

F1RL1_11 Registration of Pharmaceuticals

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

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

• Pharmacy (programme FaF, M-FARM)

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.

Syllabus

Pharmaceutical research and Development
Introduction to Registration
Activity and Importance of the Registration department
Role and Activity of the Registration Department in Production Plant
Registration of Medical Products
Registration Procedures in EU
Registrations in the USA
Registration and Registration Procedures in Asia, MENA, LATAM
Co-operation of Registration Department with Registration Authority
Registration Strategy
Regulatory Intelligence
Good Practices (GXP)
Role of registration authority

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 (in Czech)

Dialogická (diskuze, rozhovor, brainstorming)

Assessment methods (in Czech)

Dotazník

Language of instruction

Czech

Further Comments

The course can also be completed outside the examination period.

• Enrolment Statistics (Spring 2020, recent)
  
• Permalink: https://is.muni.cz/course/pharm/spring2020/F1RL1_11