Archives: Agenda

• 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

Navigating the journey from preclinical studies to market approval is a critical and complex process for medical devices. This presentation outlines a streamlined approach to ensure regulatory compliance, efficient development, and timely market access

• The importance of correct device classification and its impact on regulatory pathways.
• Strategies to define a comprehensive regulatory roadmap tailored to global requirements.
• Key preclinical tests to establish safety and performance baselines
• Insights into aligning preclinical findings with a robust clinical protocol
• Criteria for selecting the right Notified Body to streamline certification
• Best practices for creating a well-structured technical file to facilitate regulatory review

• Navigating the evolving regulatory landscape for AI and software as medical devices
• Integrating AI into existing healthcare systems
• Managing the lifecycle of AI products
• Gaining clinical experience by users of AI based SaMDs

• Increasing Clinical Trial success rate by better patient pre qualification
• Tumor boards provide personalized advice and pre qualify patients.
• Hackathons formalize, scale and tune the tumor board process
• Working to fully automate Hackathons

Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources.

• How a centralized data workbench eradicates data silos and provides near real-time access to data for optimized oversight and more efficient, data-driven decision making
• AI/ML capabilities to ensure data quality, automated data review processes, and increased productivity across the clinical development lifecycle with eIQ Review
• Proactive trial oversight and management with increased automation, comprehensive analytics, and custom visualizations in elluminate Operational Insights
• Mitigating risk with efficiency, accuracy, and ease with holistic Risk-Based Quality Management

• Leveraging early engagement to improve outcomes
• Speaking the same language – one size actually doesn’t fit all
• Mapping a development pathway with the end in mind

• Brief overview of the regulation of tobacco products
• Enforcement discretion & priorities
• Compliance & enforcement tools
• Recent enforcement actions by the agency
• Pending lawsuits

Meeting the requirements for today’s clinical trials

• Key aspects – Forecasting Accuracy Speed & Flexibility
• Meeting the challenges of todays trials – what and how to achieve
• Unified Platform – Supply Forecasting +RTSM