FaF:F1PF1_13 Industrial Pharmacy - Course Information

F1PF1_13 Industrial Pharmacy

Extent and Intensity

0/1/0. 2 credit(s). Type of Completion: z (credit).

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 of Seminar Groups

F1PF1_13/01: Wed 24. 4. 9:00–15:00 44-144, 9:00–15:00 44-144, 9:00–15:00 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: 30/30, only registered: 3/30

fields of study / plans the course is directly associated with

• Pharmacy (programme FaF, M-FARM)

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.

• Enrolment Statistics (recent)
  
• Permalink: https://is.muni.cz/course/pharm/spring2024/F1PF1_13