FARL1_11 Registration of Pharmaceuticals

Faculty of Pharmacy
Spring 2020
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
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
  • No of Lessons Topic
    2 Pharmaceutical research
    and Development
    1 Introduction to Registration
    1 Activity and Importance of the Registration department
    1 Role and Activity of the Registration Department in Production Plant
    1 Registration of Medical Products
    1 Registration Procedures in EU
    1 Registrations in the USA
    1 Registration and Registration Procedures in Asia, MENA, LATAM
    1 Co-oparation of Registration Department with Registration Authority
    1 Registration Strategy
    1 Regulatory Intelligence
    1 Good Practices (GXP)
    1 Role of registration authority
    14
Language of instruction
English
Further comments (probably available only in Czech)
The course can also be completed outside the examination period.
Teacher's information
Lectures are not compulsory.
  • Enrolment Statistics (recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2020/FARL1_11