Syllabus database for doctoral courses
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Syllabus database for doctoral courses
SYLLABI FOR DOCTORAL COURSES
| 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 Biobanking 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 | http://www.ema.europa.eu: Guidelines for GLP, GMP and GCP http://www.wma.net/en/30publications/10policies/b3/17c.pdf : Declaration of Helsinki http://www.lakemedelsverket.se/ : Swedish medicinal products agency |
Course responsible |
Evren Alici Institutionen för medicin, Huddinge 073-6261412 Evren.Alici@ki.se |
| Contact person |
