EFGCP In-house GCP Training Course for Experienced Researchers
Since its inauguration in 1993, part of the mission of the European Forum for Good Clinical Practice has been to develop education for and awareness of high ethical standards in clinical research and to facilitate knowledge transfer across sectors and disciplines. Pursuing this objective, the EFGCP has developed its own GCP Training Course for the experienced researcher. This offers an intensive one-day interactive programme that can be tailored to meet the needs of different groups involved in clinical research. The core of the course is devoted to the practical details that must be in place if a clinical trial is to be conducted to GCP standards, but the history and fundamental principles of GCP are also covered, as is what to do if things go wrong
This GCP Training Course is provided by members of the EFGCP who are recognised experts in the relevant specific fields.
Discover the EFGCP / EORTC In-house GCP Training Course for Experienced Researchers
Five years ago, the conduct of clinical trials according to Good Clinical Practice (GCP) principles was introduced as a European Union regulatory requirement by the Clinical Trial Directive 2001/20/EC. However, despite overall commitment and best intentions to apply these requirements in clinical trials, monitoring, audits and inspections regularly find complexity and lack of harmonization of varying levels of severity. This indicated a need for those involved in the conduct of clinical trials in Europe to share their experiences with this clinical trial directive.
To further promote awareness about the current legal framework, the European Forum for Good Clinical Practice (EFGCP) in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) Headquarters took the initiative to develop a one day interactive investigator training course on GCP in clinical trials. This course, “EFGCP-EORTC interactive workshop on GCP: 5 Years Experience with the EU Clinical Trials Directive and its Implications on Your Clinical Research Practice”, was held for the first time on 24 April 2009 at EORTC Headquarters in Brussels.
The topics covered in this course included GCP principles, set-up of a clinical trial at the investigative site, GCP compliance in document management, involving patients in clinical trials, critical elements of conducting clinical trials, what happens when things go wrong, and EudraVigilance - safety reporting of investigational medicinal products. The EFGCP faculty for the preparation of all course material and the workshop included Dr. Ingrid Klingmann, Expert in Drug Development Planning and Site Management Support, Pharmaplex bvba, Brussels, Belgium, Dr. Frank Wells, Expert in Misconduct and Fraud in Clinical Research, Ipswich, United Kingdom, Genevieve Decoster, ISO9000 Lead Auditor, IT & GCP Consulting sprl, Crupet, Belgium, and Prof. JanHasker Jonkman, Professor in Quality Management in Drug Research and Manufacturing, University of Groningen, The Netherlands.
The GCP Course was accredited by the Accreditation Council of Oncology in Europe (ACOE) and granted 6 European CME credits. It was attended by 60 participants representing six countries and 24 institutions in Europe.
If you would like more information about possibilities to hold an in-house GCP training in your organisation, do not hesitate to contact Fanny Senez at the EFGCP Secretariat: firstname.lastname@example.org or tel: +32.2.732 87 83
Other training modules available
EFGCP is pleased to propose ‘à la carte’ training modules to organisations and companies who seek to offer their members or employees high-quality interactive courses that will bring real added value to their knowledge and professional achievements
Fraud & Misconduct in Clinical Trials
Expert : Dr. Frank O. Wells, FFPM
Description: This module can be tailored to suit the audience and of variable length. Using the extensive experience of the trainer, the prevention, detection, investigation and prosecution of research fraud and misconduct will be covered.