Archives: Agenda

During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Bridging the gap between developers and end users to create more effective devices
Sarah Mische, Director, Clinical Affairs, Avivomed

ROUNDTABLE 2
Strategic leadership in MedTech clinical development: creating agile, high-impact trial strategies
Hatice Bilgic Lim, Director Clinical Innovation, Philips

• Solving a personal challenge to create a solution for thousands
• Marketing effectively through advocacy and community engagement
• Building credibility with clinical trials and provider partnerships
• Developing and refining software to enhance user experience and outcomes
• Navigating the regulatory environment for digital health technologies

• The sponsor’s role in building successful CRO collaborations
• Best practices that form productive sponsor-CRO relationships
• Overcoming sponsor-CRO challenges
• Managing sponsor expectations and optimizing interactions

• Exploring the impact of reduced medtech investments and cost-cutting strategies
• Trends in outsourcing and supplier consolidation to reduce overheads
• Encouraging innovation despite financial pressure

Moderator
Dave Ribble, Medical Devices Expert, GlobalData

Panelists
Al Crouse, VP of Quality Assurance and Regulatory Affairs, CVRx
Sameer Kumar, Chief Executive Officer, HabitAware Inc

• Exploring how combination products are regulated
• How to determine the primary mode of action (PMOA)
• Capturing and maintaining critical data points
• Challenges and best practices

• AI in the post-market surveillance landscape
• How AI might enhance risk management
• Regulatory considerations: presenting AI data in submissions