Agenda Archive - Page 380 of 1169 - Arena International

Chairperson’s closing remarks

PANEL DISCUSSION Streamlining compliance: agile certification for AI medical devices in the European market

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

Afternoon refreshments and networking

Exploring how digital platforms and telemonitoring are shaping clinical thinking and decision making

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

Using AI to enhance clinical trial design and efficiency

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

Commercialization of innovations and scaling up with the right business model

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

Lunch and networking

Navigating clinical data requirements for CE mark certification

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

Afternoon refreshments and networking

Morning refreshments and networking