Archives: Agenda

• We will share data collected from partner sites regarding attitudes towards decentralized trials – both positive and negative
• We will discuss different patient perspectives on decentralized trials and how these can differ based on a number of factors
• Finally, we will discuss how we can better operationalize decentralized trials by considering site and patient feedback

• Protecting Third Parties in Human Subjects Research
• Ethical, Privacy, and Safety Considerations for:
  • Direct Research Participants
  • Participant Community, Subpopulation, Race, Ethnicity, Gender
  • Society at Large
• Assessing AI Tool Bias

Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources with a centralized data workbench. Gain real-time access to data for optimized oversight, and leverage AI/ML capabilities to ensure data quality and improve productivity. See how you can mitigate risk with ease and increase automation with comprehensive analytics and custom visualizations.

Dress Code Black Tie Preferred

• Requirements for Filing
• Major Changes to Operations
• Remote Assessments? No More!
• Responsibility for Third Party Service Providers

• An overview of the tools, techniques and procedures being applied by threat actors to breach hotels
• A deep dive into current social engineering techniques
• Approaches for detecting and stopping threats

• Processing of raw milk, the fouling of plate-and-frame heat exchangers by highly viscous solutions
• Challenges in spray-dryer operation, necessitate a reappraisal of rheological-engineering approaches to manipulate (i.e., reduce) viscosity
• Engineering methods to alter and to control the viscosity of water and aqueous streams as well as their protein-agglomeration propensity
• Important implications for controlling water quality and management activities in the broader dairy industry, with many positive implications

• Identifying the key Clinical Supply Chain Metrics to measure organizational performance
• Shaping KPI and metrics targets
• Maximizing the value that metrics can provide
• Improving metrics access

Clinical utility benefit-risk analysis, unravelling insights through case studies and real-world experiences

• Understanding the significance of clinical utility benefit-risk analysis in medical decision-making.
• Identifying strategies to strike a balance between benefits and potential risks for early stage trials
• Presenting examples of actual benefit-risk assessments in clinical settings
• Addressing common challenges encountered during benefit-risk analysis
• Demonstrating how benefit-risk analysis contributes to improved patient safety and treatment effectiveness 

Unleashing the potential of software and AI as medical devices, key learnings, innovations, and overcoming obstacles

• Exploring the growing interest in using software and AI in medical applications
• Discussing the challenges and considerations in testing and regulating AI-powered devices
• Understanding the potential impact on medical imaging and other healthcare fields
• Identifying unique challenges and opportunities in this evolving field
• Discussing the impact of AI on treatment planning and decision-making
• Addressing common obstacles faced during software and AI implementation and approval
• Understanding the regulatory landscape for AI-driven medical devices
• Anticipating upcoming innovations and trends in the AI space

Exploring the future of medical device and drug combination products: insights from EMA and key considerations for MR and MDR compliance

• Understanding the increasing trend of combining medical devices and drugs
• Gaining insights from the European Medicines Agency (EMA) on the future of medical device and drug combinations
• Explaining the distinction between Medical Devices Regulation (MDR) and Medical Devices Directive (MR) for combination products
• Identifying compliance requirements and implications based on the device’s primary mode of action
• Presenting various regulatory pathways available for combination products
• Understanding how partnerships can drive innovation and development in this domain

Exploring ways to leverage CRO expertise and innovation in medical device development 

Adapting clinical trials post-covid: lessons learned, decentralised trials, and preparing for the future

• Understanding the importance of adapting trial systems for future preparedness
• Understanding the impact of technology in enabling remote and decentralised trial operations
• Discussing how DCT can improve trial efficiency and patient participation
• Discussing potential advancements in decentralised and remote trial approaches

Advancing pre-clinical talks, exploring design development, risk management, and usability in medical device development

• Discussing how certain aspects contribute to the success of medical device development
• Highlighting the importance of incorporating risk management strategies in device development
• Emphasising the value of usability considerations to enhance product performance and user experience
• Presenting case studies showcasing successful product journeys and development processes.
• Identifying when and what changes may require conducting new trials

Navigating notified bodies: looking at best practices, soft skills, and understanding the NB perspective in medical device registration

• Exploring strategies to foster productive collaborations and maximise efficiency
• Strategies for effective communication with regulatory authorities
• Exploring diverse aspects beyond clinical affairs in understanding MDR compliance
• Highlighting successful examples of company-NB collaborations in the registration process

WORKSHOP: Soft skills, leadership strategies and project management excellence

• Optimising processes, communication, and sponsor-CRO relationships in medical device development
• Exploring the diverse skills and techniques required to manage multiple projects
• Highlighting the significance of proactive project management in MDR implementation
• Encouraging the improvement of communication practices in medical device development
• Exploring methods to enhance collaboration, information sharing, and decision-making
• Implementing strategies to optimise processes and achieve better project outcomes

Unravelling regulatory loopholes in clinical trials: understanding CE-based trials, purpose-based trials, and early feasibility studies

• Defining regulatory loopholes and their significance in clinical trial operations
• Navigating regulatory pathways for trials requiring CE compliance
• Examining trials exempt from CE requirements and the associated implications
• Exploring the intersection of academic funding and adherence to regulations
• Highlighting regulatory provisions that can be advantageous for trial sponsors

Streamlining CRO selection, effective strategies and criteria for making informed choices

• Exploring the impact of CRO selection on trial success and overall project outcomes
• Identifying essential criteria for evaluating and comparing different CROs
• Emphasising the importance of effective communication and collaboration with CRO partners
• Utilising industry insights and feedback to validate CRO performance
• Developing strategies to mitigate potential risks associated with CRO selection

Fostering positive CRO relationships: tips and best practice

• Understanding the sponsor’s role in driving successful collaborations with CROs
• Identifying practices that foster productive and cooperative sponsor-CRO relationships
• Mitigating sponsor-CRO Challenges
• Addressing common challenges that sponsors pose to CROs during clinical trials
• Strategies to balance expectations and optimise sponsor-CRO interaction