ICH-GCP Essential Program

This training is aimed at medical staff wanting to work on Clinical Trials. From experience, we consider that the optimum length for this seminar is one day, but we can be flexible if required. Please contact us to discuss your specific requirements.

ICH-GCP Essential Program

AIM

To ensure the safety and well-being of subjects and patients at all times, clinical trials need to be carried out to the highest quality standards and in accordance with national and international guidelines. This seminar equips the participants with the necessary skills and knowledge for conducting clinical trials, based on a sound understanding of Good Clinical Practice (ICH-GCP), the legal framework, ethical considerations, and the roles and responsibilities of all parties involved in a trial.

Our trainers who are senior clinical research experts will expand your knowledge of the key terms and standards of clinical trials focusing on patient safety and data integrity. Interactive parts and practical exercises will strengthen your understanding of the ICH-GCP requirements.

PROGRAM OVERVIEW

  • Guidelines and Laws in Clinical Research (including ICH-CGP regulations)
  • International and local clinical trial management practices
  • Essential Study Documents
  • Guidelines and Laws in Clinical Research
  • Roles and Responsibilities according to Good Clinical Practice
  • Safety Reporting
  • Real-world case studies