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