Archives: Agenda

• Prediction of operational efficiency of clinical trials by machine learning models
• Prediction of early trial termination of clinical trials
• Prediction of adverse event reporting in clinical trials

• Exploring the conjunction between medical devices and digital health
• What are the success factors?
• Dos and don’ts and best practice examples

• Real-world data generation for clinical studies on remote patient monitoring
• Exploring the future role of remote patient monitoring in drug approval
• The role of digital platforms in enhancing data collection for medical device trials

• Highlighting the main components of the act
• How the AI Act complements or adds to MDR requirements
• Balancing innovation with safety
• Strategies to navigate the AI Act

Conducting medical device clinical trials in Europe and the UK presents unique challenges due to varying regulatory landscapes and operational complexities. This session highlights the key issues faced by researchers and companies in this region, including:

• Planning for varying local and regional regulatory requirements
• Coordinating operations across multiple countries
• Streamlining patient recruitment and data management

• Commercial pressure versus Clinical realities
• Managing the tripartite relationship between Sponsor, CRO and Site.
• Key drivers of failure (and success!)
• The changing clinical trial landscape: Adapting to new challenges

• Examine critical regulatory pathways, with strategic insights for achieving market clearance/approval in the US and EU
• Present streamlined approaches for planning and designing effective clinical studies, highlighting the benefits of budgeting early
• Discuss efficient processes for regulatory submissions and applications, from clinical study conduct to market clearance/approval