AIM
This seminar provides a broad overview of key aspects of conducting a global clinical trial. It helps you to understand the latest trends in the pharmaceutical industry and to master international and local clinical trials in practice. On completion of this course you will have a clear understanding of the laws and regulations governing the conduct of clinical trials today and the significance and impact of Good Clinical Practice. You will be familiar with the procedures for setting up a trial, requirements for site participation and exactly what happens at qualification and initiation visits, monitoring visits, audits and inspections. You will know about the quality assurance mechanisms for ensuring compliance, patient safety and data validity.
PROGRAM OVERVIEW
- Introduction to Clinical Trials
- International Ethical Principles and Guidelines (including ICH-CGP regulations)
- Roles and Responsibilities in Clinical Trials
- Applicable Regional and/or National Laws and Guidelines
- Essential Study Documents
- Site Selection / Site Initiation
- Monitoring and Adverse Event Reporting
- Real-world case studies
