Good Clinical Practice Symposium

This virtual workshop follows previous joint events between the United Kingdom’s Medicines and Healthcare product Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA). At this event, the MHRA and FDA welcome Health Canada (HC) to the collaboration.

The COVID-19 pandemic has necessitated flexibility in trial conduct and accelerated changes in the clinical trial landscape. Regulators have also provided new guidance on trial conduct, taking a pragmatic and proportionate approach for trials being conducted during the pandemic. Moving forward, it will be important to leverage the use of more innovative tools and approaches to trial design, conduct, and inspections, including remote approaches.

This event will provide regulatory perspectives on how maximising our understanding and use of risk-based approaches can build resilience into clinical trials, allowing flexibility in the protocol and clinical trial conduct while still ensuring participant safety and reliable results. We will discuss continuing developments in decentralised trials, use of real-world data and real-world evidence in regulatory decision making, and the importance of sponsor oversight.

The event will also include sessions dedicated to the conduct of bioequivalence (BE) trials. Regulators will provide their perspectives on common issues and challenges in the conduct of the clinical and bioanalytical components of BE trials and provide important updates on guidance and inspection activities.

At this event, participants will learn:

• Key aspects of building resilience into clinical trials
• Risk-based approach to sponsor oversight
• Use of real-world data/real-world evidence
• Updates regarding decentralised trials
• Changes in clinical trial activities and inspections
• Sponsor oversight of vendors
• Potential uses of artificial intelligence and machine learning in clinical trials
• Clinical and bioanalytical challenges in bioequivalence trials
• Updates in guidance and inspection approaches