Archives: Agenda

• 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

• 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

• 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

• The impact of AI and cyber threats on medical devices
• The cyber challenges 2025 may bring
• How regulators and tech companies are meeting the AI challenge

• Analysis of current trends in investment within the medical device sector and exploring what factors contribute to the investment gap
• Discussing financial, operational and regulatory challenges that startups and small to medium-sized companies face in the industry and how to overcome them
• Identifying potential solutions for improving the investment landscape

• Challenges and opportunities from a technology, economic perspective
• Geopolitical, legal and regulatory changes and their impact from an ecosystem perspective

• Discussing challenges in communication, project management, and regulatory compliance
• Role of CROs in fostering innovation in medical device development
• Case studies highlighting successful collaborations and lessons learned
• Emerging trends and technologies shaping future collaborations