Syllabus database for doctoral courses

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Swedish title Introduktion till GLP, GCP och GMP
English title Introduction to GLP, GCP and GMP
Course number 2542
Credits 1.5
Notes The course meets the requirements for a general science course.

Responsible KI department Institutionen för medicin, Huddinge
Specific entry requirements
Grading Passed /Not passed
Established by The Board of Doctoral Education
Established 2011-03-31
Purpose of the course
Intended learning outcomes The aim for the course is to teach the students advances in Good Laboratory Practice (GLP), Good manufacturing practice (GMP) and basics in good clinical practice (GCP). Ethical aspects regarding animal and clinical research will also be briefly covered. Finally, there will be a session regarding the Swedish and European biobanking rules and regulations.
At the end of the course, the participant will have a detailed knowledge on:
Rules, regulations and ethics in laboratory environments
Ethics and routines for first-in-man clinical trials
Practical and theoretical basis for GMP
Ethical aspects of translational research
Contents of the course Good Laboratory Practice: Regulations in KI, Design and protocols, logging,
Good tissue and good cell culture practice: Regulations and examples
Good manufacturing practice: Legal aspects, designs and protocols, Logging, quality controls and examples
Good clinical practice: Statistical planning and analysis, regulations, preparation for a clinical trial introductory overview
Compiling the GLP-GMP-GCP map

Teaching and learning activities Case scenarios, Group work, and Lectures
Compulsory elements All the events are obligatory to ascertain a pass.
Examination The participants will be assesed by a written take-home examination.
Literature and other teaching material Guidelines for GLP, GMP and GCP : Declaration of Helsinki : Swedish medicinal products agency
Course responsible Evren Alici
Institutionen för medicin, Huddinge


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