Archives: Agenda

• Learning how the agile certification process prototype harmonizes the MDR and AI Act, creating a streamlined path for innovative AI technologies to meet stringent regulatory standards
• Understanding the importance of effective change management in maintaining compliance throughout the lifecycle of AI medical devices

• 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

• 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

• Understanding regulatory expectations
• Designing and conducting clinical investigations
• Balancing data sufficiency with practicality

• 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

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