GCP TRAINING (GOOD CLINICAL PRACTICES)
1-DAY PROGRAM - GROUP
The GCP program provides attendees with intensive training for an in depth understanding and a thorough knowledge of the clinical research process, roles and responsibilities of the important players and regulatory requirements. The course consists of both lectures and practical exercises.
N.B. The ICH-GCP (International Conference on Harmonization – Good Clinical Practice) Guideline was developed in order to provide a unified ethical and scientific quality standard for conducting clinical trials that involve human subjects in the EU, Japan, and the United States. Since the incorporation of the guideline in European directives and their subsequent mandatory implementation in the national legislations of the individual member states of the EU, they are legally binding throughout the European Union.
TARGET GROUP: Clinical investigators, study coordinators, regulatory and Medical personnel, clinical research associates, clinical trial assistants, auditors and any other person willing to be informed about GCP.
|DAY 1: |
BRIEF HISTORY OF ICH GCP AND THE EU DIRECTIVE
RESPONSIBILITIES OF THE SPONSOR/INVESTIGATOR
PROTECTION OF THE SUBJECT
PREPARATION FOR AUDIT