Good Laboratory Practice

Thursday, September 3, 2026
9:00 a.m. - 4:30 p.m.

Description

Good Laboratory Practice (GLP) is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported." (OECD Principles of GLP) GLP is regulated worldwide in different laws and regulations (the predicate rules) and builds the bridge between university research and (regulated) industrial research. Studies conducted under GLP focus on safety aspects of new compounds like chemicals, pharmaceuticals, pesticides, and food additives. 

On the first day, you will gain understanding and knowledge of GLP principles, their role in data integrity, and their importance for trustworthy data as crucial part of the development process. All phases of a GLP-study, including planning, conduct, reporting and archiving, will be discussed. In addition, requirements concerning qualified equipment, validation of computerised systems as well as good documentation practice will be addressed. Moreover, we will highlight the difference between a good and a bad quality culture and the importance of critical thinking and risk management, a core process in every regulated pharmaceutical company.

On the second day, we will make a step beyond the lines of GLP into the world of clinical development and GCP and briefly look at Medical Devices and Medical Device Software, an emerging topic during clinical drug development.