Good Laboratory Practice

Thursday, March 14, 2024
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 on 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 Day 1, the workshop will promote the 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 and the difference between a good and a bad quality culture will be highlighted.

The workshop is designed for those who wish to know more about regulated industrial
research. It provides an opportunity for beginners to build their competencies in that area and to actively engange with an experienced subject matter expert on Electronic Records-Electronic Signatures (ER-ES) regulation.

During Day 2 of the workshop we will highlight the importance of critical thinking and discuss foundational aspects of risk management, a core process in every regulated pharmaceutical company. Finally, we will make a step beyond the lines of GLP into the world of clincial development and GCP and briefly look at Medical Devices and Medical Device Software, an emerging topic during clinical drug development.