Good Laboratory Practice
A workshop offered by the Bonn Graduate Center
Good Laboratory Practice is regulated worldwide in different laws and regulations (the predicate rules) and builds the bridge between university research and (regulated) industrial research. This 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.
In-person Workshop
Thursday, March 14, 2024
9:00 a.m. - 4:30 p.m.
Friday, March 15, 2024
9:00 a.m. - 12:00 p.m.
Trainer
Dr. Simon Pflug
Language
English
Location
Alte Sternwarte
Poppelsdorfer Allee 47*
Target Group
Doctoral students and postdocs
Track(s)
Research, Business and Organizations
Certificate
12 units are applicable within the Doctorate plus or Postdoc plus certificate
* The premises are not barrier-free. Please contact the Bonn Graduate Center if you need assistance.
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.
Content
- GLP basics (definitions, principles, regulation)
- Main phases of a GLP study, including multisite studies
- Roles and responsibilities in a GLP test facility
- Data Integrity basics, including ALCOA+ principles
- Introduction into clinical development and Good Clinical Practice (GCP)
Contact
Bonn Graduate Center
Address
Alte Sternwarte
Poppelsdorfer Allee 47
53115 Bonn
More Workshops?
Have a look at further workshops offered in our Doctorate plus program this semester.
Also see
Certificate Doctorate plus
Acquire the Doctorate plus Certificate in one of our three career tracks.
Qualification Program Doctorate plus
Expand your skills with our qualification program Doctorate plus.
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