Good Clinical Practice Training

This course provides comprehensive guidance on all aspects of Good Clinical Practice (GCP) guidance, specifically focusing on the significant changes introduced in ICH E6(R3).

The objective of this interactive 8-hour course is to highlight the need for an effective and connected QMS that embeds QbD throughout and adopts a risk-based approach. If your organisation wants to understand what the changes are and what needs to be done differently, then this is the course for you, demonstrated through presentations, group discussions and case examples.

By the end of this GCP training course, you will:

• Be able to outline the key principles of GCP and the regulatory landscape with a key focus on ICH E6 (R3)
• Understand the ethical considerations around informed consent and confidentiality and data protection
• Define the roles and responsibilities of Investigators, Sponsors, Monitors and IRBs
• Understand the requirements for study design and protocol compliance
• Be able to define Adverse Event Management, Safety Monitoring and Reporting
• Have an awareness of, and have received information on, Quality Assurance, preparing for inspections and current GCP inspection findings, data integrity and protocol deviation management

• Affiliate/country quality assurance (QA) teams and clinical trials teams
• GMP experts, auditors, QPs, and quality control and technical specialists
• GCP and GMP managers wishing to gain an understanding of this GXP interface and current regulatory hot topics

Mandy Cooke – Mandy is a senior quality and regulatory expert with a proven track record in designing and implementing enterprise-level GxP-compliant Quality Management Systems across global pharmaceutical organisations. Extensive experience in interpreting and operationalising evolving regulatory requirements through risk-based and quality-by-design principles.