Good Research Practices: GCP/GLP

 

The course takes place during seven days from 9 a.m. to approximately 3 p.m. and is a mixture of lectures, site visits to a GCP-certified clinical research center and a GLPcertified laboratory, demonstrations, interactive video training and case studies (group presentations). Participation requires thorough preparation studying abstracts and literature, which will be provided before the start of the course, and doing active research of the subject on the Internet.

• General principles of quality management applied to drug research: Good Research Practices: GxPs
• Legal and ethical aspects of new drug development
• Good Clinical Practice (GCP) (ethical aspects: preparing, performing and evaluating a clinical study with a potential new medicine)
• Good Laboratory Practice (GLP) in the Bioanalytical Laboratory and Analytical Laboratory; preparing, performing organizational and technical aspects and evaluating a bioanalytical or analytical study
• Bioanalysis and analysis in the context of new drug development according to GLP
• Implementation of GxPs
• Compliance with GxPs 

Study load

3 ECTS credit points

 

Calendar

March 18 - 27, 2013

 

Registration

Ms. M.H. (Maaike) Bansema (m.h.bansema@umcg.nl)

Phone: +31 50 363 8409

 

Coordinator
prof. J.H.G. Jonkman

 

Additional information

...