Good Laboratory Practice and Accreditation, 1.5 credits

Entry requirements

Entry requirement for studies on third-cycle education courses

• second-cycle degree,
• 240 credits in required courses, including at least 60 second-cycle credits, or
• acquisition of equivalent knowledge in some other manner

Learning outcomes

By the end of the course the students will be able to:

Knowledge and understanding

• Account for good laboratory practice (GLP and some ISO standards), as well as other standards (GCP, Good Clinical Practice, and GMP, Good Manufacturing Practice)

Competence and skills

• Apply good laboratory practice in planning and performance of scientific studies (clinical as well as preclinical)

Judgement and approach

• Analyze the relationship between a study's quality and compliance with a standard.

Contents

In this course, the student will acquire the basics on accreditation standards and processes, with a primary focus on good laboratory practice (GLP). Introduction to other standards including GCP and GMP will also be given. The course is designed to be informative for students performing preclinical laboratory studies as well as those performing clinical work and research.

Educational methods

The pedagogical approach applied at the Faculty of Medical and Health Sciences is student centered, problem-based learning (PBL). The student takes responsibility for his/her own learning and seeks and evaluates information and knowledge based on own queries and formulated problems. The role of the teacher is to guide and support the students.

Educational methods applied in this course are lectures and seminars.

Examination

The course is examined through an individual seminar assignment including oral presentation and discussion.

Students who fail are offered one re-examination occasion in close connection to the course. After that participation in a coming course examination is offered. The re-examination should be equally comprehensive as the ordinary examination.

Change of examiner

Students who have failed the course or part of the course twice are entitled to request another examiner for the following examination occasion.

Grading

Pass or Fail

Course certificate

On the student’s request, course certificate is issued by the course examiner.

Grading

Course literature

A list of recommended literature will be provided by the course coordinator before the start of the course.

General information

The course is planned and carried out according to what is stated in this syllabus. Course evaluation, analysis and suggestions for improvement should be fed back to the Research and PhD studies Committee (FUN) by the course coordinator.

If the course is withdrawn or is subject to major changes, examination according to this syllabus is normally offered at three occasions within/in close connection to the two following semesters.