This course is discontinued

FRM2020R – Production, Quality Control and Distribution of Medicinal products

Schedule, syllabus and examination date

Choose semester

Course content

The course addresses the quality control and distribution of medicines. Quality assurance is central and the current laws, regulations and guidelines dealing with this are included in the course.
The course is made up of the following subject areas: analysis of medicines, pharmaceutical microbiology and community pharmacy.

Learning outcome

The course will give students a thorough understanding of the chemical and microbiological quality control of finished medicinal products and the associated quality assurance principles. Students will also gain knowledge about the various participants in the business of medicines, insight into the logistics of medicines, and an understanding of the meaning of quality assurance and quality control in the distribution chain. Students will attain knowledge of the laws and regulations that are important in connection with the distribution and quality control of medicines. The laboratory course covers the chemical and microbiological quality control of finished products. The project assignment will give students a deeper understanding of issues relating to the distribution of medicinal products.

Admission

The course is only available to students with a 3-year norwegian bachelor degree in pharmacy and inrolled at the School of pharmacy at the University of Oslo

Prerequisites

Formal prerequisite knowledge

Alternative studyplan for "reseptarer" to the 5-year masterprogramme in pharmacy.
In order to participate in this course, all manditory activities from FRM1010 and FRM2010 must be approved.
To sit for the exam: FRM1010 and FRM2010 must be passed.

Health, Safety and Environment (HSE)
There are compulsory HSE courses at the beginning of the first semester. For students commencing their program from the autumn semester 2015 the following courses are mandatory:

In addition to this you will have to complete HMS0503 - Laboratory Safety and HMS0506 Patient clinic Safety for participation in Laboratory and clinic-courses in the program.

You will need to provide documentation that you have passed HMS0501, HMS0502, HMS0503 HMS0506 and HMS0507 when you attend the first mandatory lab.

For students who commenced the program from the Autumn semester 2012 up til and including the spring semester 2015 the following courses are mandatory:

  • MNHMS0015 - Introduction to Health, Safety and Environment (HSE) (discontinued) or HMS0501 - Safety and Physical Environment and HMS0502 - Positive Learning Environment and HMS0507 - Fire Safety.
  • MNHMS0010LS - Introduction to Laboratory Safety (discontinued) or MNHMS0020LS - In-Depth Laboratory Safety (discontinued) or HMS0503 - Laboratory Safety
  • MNHMS0015FS - Introduction to Field Safety (discontinued)  or HMS0504 Field Safety.

    For more information on the HSE courses and transitional arrangements:
    http://www.mn.uio.no/english/studies/courses/hse-courses.html

Teaching

The course includes lectures, group work, seminars, laboratory work, and project work. The laboratory work is compulsory as are the project work and the presentation of the project.
The laboratory and project work, and the presentation of the project, need to be approved in order for the student to be eligible to take the written exam.

Inactivity and / or excessive absences in compulsory education means that the student does not receive final assessment / examination.

As the teaching involves laboratory and/or field work, you should consider taking out a separate travel and personal risk insurance. Read about your insurance cover as a student.

Access to teaching

A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.

Examination

A three hour written exam

Examination support material

As of 1 August, 2016, the use of own calculators is no longer permitted. Casio FX-991EX calculators are handed out to all exam candidates at the beginning of the exam.

Language of examination

You may submit your response in Norwegian, Swedish, Danish or English. If you would prefer to have the exam text in English, you may apply to the course administrators.

Grading scale

Grades are awarded on a scale from A to F, where A is the best grade and F is a fail. Read more about the grading system.

Explanations and appeals

Resit an examination

This course offers both postponed and resit of examination. Read more:

Withdrawal from an examination

It is possible to take the exam up to 3 times. If you withdraw from the exam after the deadline or during the exam, this will be counted as an examination attempt.

Special examination arrangements

Application form, deadline and requirements for special examination arrangements.

Evaluation

The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.

Other

This is a subject from the alternative studyplan for reseptarer.
The reseptar-students follow the regular lectures and all regular activities as for FRM2020, but will have an alternativ exam marked R. All reseptar-students must follow the lectures concerning Qualitycontroll and distribution.
They are exempted from Production of drugs.

Facts about this course

Credits

6

Level

Bachelor

Teaching

Every spring

The curriculum is being revised. The course is taught for the last time spring 2017.

Examination

Every spring

Teaching language

Norwegian