Kursplansdatabas för forskarutbildningskurser
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Kursplansdatabas för forskarutbildningskurser
KURSPLANER FÖR FORSKARUTBILDNINGSKURSER
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| Svensk benämning | Introduktion till GLP, GCP och GMP |
|---|---|
| Engelsk benämning | Introduction to GLP, GCP and GMP |
| Kursnummer | 2542 |
| Antal högskolepoäng | 1.5 |
| Noteringar |
Kursen uppfyller kraven för en allmänvetenskaplig kurs. |
| Kursansvarig institution | Institutionen för medicin, Huddinge |
| Särskild behörighet | |
| Betygsskala | Godkänd/Icke godkänd |
| Fastställd av | The Board of Doctoral Education |
| Datum för fastställande | 2011-03-31 |
| Kursens syfte | |
| Kursens lärandemål | 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 |
| Kursens innehåll | 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 |
| Arbetsformer | Case scenarios, Group work, and Lectures |
| Obligatoriska moment | All the events are obligatory to ascertain a pass. |
| Examination | The participants will be assesed by a written take-home examination. |
| Kurslitteratur och övriga läromedel | 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 |
Kursansvarig |
Evren Alici Institutionen för medicin, Huddinge 073-6261412 Evren.Alici@ki.se |
| Kontaktpersoner |
