Good Clinical Practices, a comprehensive program - 2 days course and workshop 

The purpose of this course and workshop is to provide an all-inclusive background in Good Clinical Practices (GCPs) for clinical trials conducted in worldwide. This course emphasizes GCP requirements and quality assurance functions for clinical trials for the sponsor-monitor and their QA groups, Institutional Review Boards (IRBs), the clinical investigators, and regulatory authorities.

Course Overview

The Good Clinical Practices program provides the participant with a comprehensive background in Good Clinical Practices, a guideline of the International Conference of Harmonization and the FDA/GCP requirements.

The 2 day course and hands on workshop allows the participant to understand the responsibilities of the clinical investigator, sponsor and institutional review boards (IRB) or ethics committees. A complete background analysis of requirements for medical research is presented with the analysis of the Declaration of Helsinki and the Belmont report.

The entire presentations are done with sample cases that are specific to the guidelines presented to assist the participant put into practice GCPs. An in depth review of FDA issued warning letters to clinical research stakeholders is analyzed to further enhance the concepts and regulatory responsibilities.

Who should attend

This two-day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Medical Devices and allied industries with daily responsibilities in the following areas:

  • Clinical research
  • Regulatory affairs
  • Quality Assurance
  • Medical writing
  • Product development
  • Project Management
  • Consultants
  • Training
  • Others
Certificate of Attendance

All participants will receive  dual Certificates of Attendance issued by EduPharma and The Clinical Research Institute of America.