• Background and rationale of the EU regulatory framework on AI
• Main elements of the regulatory framework on AI
• Interlink with existing EU legislation on medical devices
• Understanding what questions you should be asking
• Learning how your companies should be supporting you

Speakers:

Gabriele Mazzini
Legal and Policy Officer
European Commission

Salvatore Scalzo
Policy and Legal Officer, AI
European Commission

• Introduction, What is medical device software?
• MDCG Guidance on Software
• Software qualification and classification
• General Safety and Performance Requirements
• State of the Art and AI

Speakers:

Dr Fiona Dunn
Senior Technical Specialist & Scheme Manager, Active Devices, Medical Devices
BSI

Dr Aris Tzavaras
Technical Specialist & Scheme Manager, Active Devices, Medical Devices
BSI

• General Data Protection Regulation review related to software and AI
• Creating value with data, AI and the re-identification of anonymized datasets
• Where does the line cross for things like heart rate monitoring (ie. data re-use to improve services, data disclosures to third parties etc.)?
• What are the rules around CE marking for these companies?

Speakers:

Jan Dhont
Partner, Privacy and Cybersecurity
Wilson, Sonsini, Goodrich & Rosati

Nikolaos Theodorakis
Of Counsel
Goodrich & Rosati

Laura Brodahl
Associate
Goodrich & Rosati

Data plays the fundamental role in a clinical trial. As medical technologies continue to advance, the sources of data collection are expanding past just one clinical trial database. Methods including but not limited to wearables, mobile applications, eDiaries, real-world evidence, outcome assessments, imaging, EHRs and EMRs are all sources for data collection and can be housed in different places. It’s critical for companies to successfully manage and identify meaningful, actionable insights that impact a trial. By using an intuitive data visualization tool, large amounts of sensitive trial data from various sources can be translated into meaningful information in just one application. Join us to learn more about how data visualization increases efficiency in the incredibly complicated clinical trial process.

• Why: Benefits and Advantages of Data Visualization Technologies in Clinical Trials
• What: Power BI Dashboard and Reporting Tool
• How: Using Data Pooling and Automation to Visualize Real-Time Clinical Study Data
• Case Studies: Successful Uses of Power BI Visualization in Clinical Trials Today

Speakers:

Mark McIlduff, MS, MBA
General Manager, U.S. Operations
Avania

Hailey Jannetty, MS
Sr. Data Analyst
Avania