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