2-Days Practical Hands On Course and Workshop

This is the largest and most comprehensive change to GCP/ICH since its implementation in 1997. Adopted in November 2016 has to be implemented in an effective and seamless manner. This course and workshop will provide clinical trial professionals of all extractions with the understanding of the implications of the changes and how to implement them effectively .

Introduction

This 2 days fully interactive hands on course and workshop was designed to discuss how the new changes to GCP will affect your clinical research enterprise.

Major changes (26 items changed) have been introduced that will affect the processes and procedures as well as responsibilities of the Investigator and the sponsor (and CROs) of clinical trials.

The topics affected by the changes that are covered in this course and workshop include:
  • source documentation,
  • validation of computerized systems,
  • monitoring, 
  • quality management, 
  • risk assessment,
  • data integrity
  • QA root cause analysis (RCA)
  • QA CAPA (corrective and preventative actions) 
  • others.

Who should attend?

  • Clinical Research Associates
  • GCP/QA inspectors
  • Clinical Project Managers
  • IT Clinical professionals
  • Monitors of clinical trials
  • Clinical Research Scientists
  • Directors/Managers of QA GCP
  • Directors/Managers Clinical Research Operations
  • Investigators of clinical trials
  • Coordinators of clinical trials, and
  • all other professionals involved in clinical trials

Which are the requisites to participate?

Have previous experience in clinical researcher and knowledge of GCP/ICH

How to register?