This event has already taken place.
Performance of clinical trials according to Good Clinical Practice (GCP) principles has been introduced as a European regulatory requirement by the Clinical Trial Directive 2001/20/EC and is also now the basis for the EU Clinical Trial Regulations 536/2014. Strict adherence to this standard ensures patient protection and reliable data. It is the basis for acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly find deficiencies of different levels of severity.
In this interactive workshop current experience and requirements of GCP-conform set-up and performance of clinical trials will be presented, their practical implications and examples discussed and pragmatic solutions for daily practice elaborated.
Topics included are:
At the end of the course, you are able to:
Participants who succesfully complete the test at the end will receive a "EFGCP GCP Certificate of Completion"
An important part of preparing for any further professional step is becoming (more) aware of the competences you have developed and/or want to develop. In the current workshop, the following competences from the UHasselt competency overview are actively dealt with:
When and where?