EFGCP to Establish Changes in GCP Training


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-01-01-2011
Volume 20
Issue 1

GCP training will be the main point of discussion at the EFGCP meeting in February.

GCP training will come under the spotlight at the start of February, when the European Forum for GCP's annual congress takes place in Budapest, Hungary.

The two-day meeting will bring together experts from a range of clinical trial disciplines to discuss the needs of the key players. The organizers' prime aims are to exchange national and organizational experiences and to devise constructive proposals for meeting GCP training needs.

The European Forum for GCP's annual congress will take place in Budapest, Hungary; Livio Sinibaldi/Getty Images

"Although the European Commission has established a comprehensive regulatory package to ensure that GCP principles apply to the conduct of clinical trials within Europe, it is very apparent that the practical implementation of this regulatory package differs between member states," state the organizers.

Training must be appropriate for each partner, whether it is an industry or academic sponsor, ethics committee, competent authority, or investigator. This training is often inadequate, inconsistent, and too theoretical. This has to be addressed, as does the need to ensure that patients and the public are more aware of the benefits and risks of taking part in studies involving the use of rigorous standards, according to officers from the EFGCP.

Two important initiatives being considered by EFGCP are the creation of a common curriculum and provision of certification and accreditation. The keynote address from Jean-Pierre Tassignon, MD, PhD, President of Crossover CRI (Zug, Switzerland), will ask whether harmonized training standards are really necessary.

The event, called "Certified GCP Training—Needs and Solutions," is being held February 1- 2, and is supported by the Hungarian Clinical Trial Management Society. Its seven workshops will address e-GCP training, how to teach clinical research to medical students, training of experienced investigators and responsibilities for training their teams, the suitability of SOPs as training tools, how to train risk-benefit assessment in rare diseases, the contribution of patients in ethics committees, and special training for research involving older people and geriatric patients.

The conference will also include an update on the PatientPartner project to be given by Cor Oosterwijk, PhD, from The Netherlands. PatientPartner is a three-year European Union FP7 (Seventh Framework Program) project investigating, enforcing, and advising on the role of patient organizations in clinical trials (www.patientpartner-europe.eu). Its main goals are to make inventories of the needs of patient organizations; to identify and realize common points of action amongst all stakeholders by engaging in an active dialogue; to realize the European Network of Patients Partnering in Clinical Research (ENPCR); to create a European network for interaction with the other stakeholders in the clinical trial field; and to create European, patient-centred guiding tools and recommendations on how to create a successful partnership.

PatientPartner organized a training workshop in Brussels on December 7-8, 2010, and in his Budapest presentation, Oosterwijk will present details about the results of the workshop. —Philip Ward

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