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European Forum for Good Clinical Practice

EFGCP In-House GCP Training Course for Experienced Researchers

Practical Information

Commencing Date:
Anytime
Language:
English
Location:
Europe


Teaching Methodology:
Face-to-Face


Scholarship Possibilities:
No

Course Contact

Fanny Senez

+32 2 732 87 83

fanny.senez@efgcp.eu


Website

European Forum for Good Clinical Practice

University Accreditation: No

Individual Course

Description

This course 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. Other topics tackled include setting up 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. This GCP Training Course is provided by members of the EFGCP who are recognised experts in the relevant specific fields. Also available in German.

Methodology

Quality - GMP, GCP, GLP

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered