F1PF1_13 Industrial Pharmacy

Faculty of Pharmacy
Spring 2022
Extent and Intensity
2/1/0. 4 credit(s). Type of Completion: zk (examination).
Teacher(s)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (lecturer)
prof. PharmDr. Mgr. David Vetchý, Ph.D. (seminar tutor)
Guaranteed by
prof. PharmDr. Mgr. David Vetchý, Ph.D.
Department of Pharmaceutical Technology – Departments – Faculty of Pharmacy
Timetable
Wed 13. 4. 8:00–17:00 44-144, Thu 14. 4. 8:00–17:00 44-144
Course Enrolment Limitations
The course is only offered to the students of the study fields the course is directly associated with.

The capacity limit for the course is 30 student(s).
Current registration and enrolment status: enrolled: 2/30, only registered: 0/30
fields of study / plans the course is directly associated with
Course objectives
Industrial Pharmacy offers a view into the pharmaceutical industrial company producing the drug substances as well as the medical products. Students can follow the whole process from the drug development and evaluation, the formulation of an appropriate medical form, quality assurance of medical products to clinical studies and the documentation preparation for the registration procedure.
Learning outcomes
After completing the course, the student will be able to:
- describe the regulatory principles of pharmaceutical production;
- describe the factors that are important for good practice and quality management in pharmaceutical research and production;
- identify and describe procedures for technological and analytical development and stability testing;
- apply the principles of pharmacovigilance and pharmacoeconomics;
- apply procedures for creating registration dossiers
Syllabus
  • Elective subject: INDUSTRIAL PHARMACY
    Extent: 3 hours per week
    Form: lectures and practice in blocks in industrial companies
    Exam: written test
    Lectures:
    1. Regulatory principles.
    2. Development and formulation in pharmaceutical technology.
    3. Analytical development and stability testing.
    4. Clinical trials and the role of clinical department.
    5. Pharmacovigilance
    6. Good practices and quality assurance in pharmaceutical research and production.
    7. Registration documentation.
    8. Pharmacoeconomics.
    Practice: excursion in pharmaceutical company.
Teaching methods
lectures, excursions
Assessment methods
written test
Language of instruction
Czech
Further comments (probably available only in Czech)
The course can also be completed outside the examination period.
Teacher's information
Test in pharmaceutical company.
The course is also listed under the following terms Spring 2020, Spring 2021, Spring 2023, Spring 2024, Spring 2025.
  • Enrolment Statistics (Spring 2022, recent)
  • Permalink: https://is.muni.cz/course/pharm/spring2022/F1PF1_13