- March 7 - 9, 2022
- 7:30 AM - 12:00 PM ET
FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada will provide attendees with insight into key topics, compliance trends and the opportunity to hear first-hand from regulators about lessons learned from the changing clinical trial landscape.
- Key aspects of building resilience into clinical trials
- Risk-based approach to sponsor oversight
- Use of real-world data/real-world evidence
- Updates regarding decentralized 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
The COVID-19 pandemic has necessitated flexibility in clinical trial conduct and accelerated changes in the clinical trial landscape. Moving forward, it will be important to leverage the use of innovative tools and approaches to trial design, conduct, and inspections. This event will build on the February 2020 GCP Symposium: Data Integrity in Global Clinical Trials – Tackling Challenging Topics in 2020. Presenters will provide regulatory perspectives on how maximizing 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. Presenters will discuss continuing developments in decentralized 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.
|FDA Presentations from MHRA HC FDA Conference||pdf (2.89 MB)|