Trainee Name Trainer Mr JeanPaul Eycken CEO FormaliS SA This ICH E6R2 GCP Investigator Site Training meets the Minimum Criteria for ID: 685500
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Trainee:
NameTrainer:Mr. Jean-Paul EyckenCEO FormaliS SAThis ICH E6(R2) GCP Investigator Site Training meets the Minimum Criteria for ICH E6(R2) GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Good Clinical Practice for Investigator Site Teams& Ethics Committees version 2.00
This document certifies that the trainee has successfully attended and actively participated in the “Good Clinical Practice” Trainingorganized by FormaliS on Date VenueThe trainee’s test results at the end of the course met the minimal criteria ( >80% correct answers)for receiving this certificate each ticked box indicates a training session attended by the participant
Program The Principles of ICH E6(R2) Good Clinical Practice GCP – 10 Rules of the ThumbBreak Responsibilities in a Clinical Trial Training TestAdditional documentation:ICH E6(R2)-GCP Guideline for GCPFDA Guidance for IndustryExample of an FDA Warning Letter
Training Certificate
F
ormali
S
The Quality Experience
Registered Office:
FormaliS SA
50 Esplanade
L-9227
Diekirch
LUXEMBOURG