- Understanding the requirement and options for declaring biological materials to U.S. Customs and Border Protection (CBP)
- Review of key U.S. regulatory agency authorities, such as CDC, FDA, USDA, and CBP
- Discovering the latest non-compliant shipment issues for biological materials and pharma products and tips to avoid them
- Learning about valuable resources and contacts for assistance
Archives: Agenda
END OF DAY 1 AND NETWORKING DRINKS
Registration and refreshments
Propelling asset development through integrated regulatory, clinical, and medical expertise
- Discover the benefits this model brings to strategic asset development
- Understand the optimal timepoints for CRO engagement
- Discuss tips for maximizing your CRO’s expertise to support a comprehensive development plan
- Review real-world examples demonstrating the advantages of this approach
Enhancing clinical trial integrity: safeguarding endpoints with patient technology
- Ensuring data accuracy: utilize eCOA to capture patient-reported outcomes in real-time, reducing errors and enhancing data reliability
- Streamlining patient enrollment: implement IRT to manage patient randomization and drug supply logistics, ensuring compliance and minimizing risks of bias
- Enhancing patient compliance: leverage eConsent to provide clear, accessible information to participants, ensuring informed consent and improving retention
- Strengthening data security: integrate robust encryption and authentication measures across eCOA, IRT, and eConsent platforms to protect sensitive data and maintain trial integrity
- Facilitating regulatory compliance: ensure all digital tools comply with regulatory standards (eg FDA, EMA) to streamline approval processes and enhance trial credibility
PANEL: Fostering a strong relationship with your CRO to make your trial a success
- Technology and new developments when it comes to managing CRO relationships
- How to ensure your study is prioritized
- Maintaining a strong relationship with vendors in remote and hybrid work settings
- How to blend a CRO team with your internal team in order to foster communication and overall success of your trial
- CRO monitoring and oversight: how to make processes efficient and effective
Afternoon refreshments and networking break
PANEL: Achieving diversity and inclusion in patient recruitment
- DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
- Navigating FDA regulations and devising a strategy for diversity and inclusion
- Building trust and relationships with communities who may not traditionally participate in clinical trials
- Working with advocacy groups to increase trial diversity and patient numbers
MODERATOR:
Robert Loll, Senior Vice President, Business Development and Strategic Planning, Praxis
Accelerating clinical trials with meaningful AI
Explore how artificial intelligence is revolutionizing the speed, quality, and consistency within clinical trials through innovative technologies and real-world applications. This presentation explores:
- Preparing your organization
- How to identify AI opportunities and associated value
- Real life examples of using AI to accelerate clinical trials
Assessing patient attitudes to the use of AI in clinical trials
- Review the results of a public and patient survey on the use of AI to develop clinical trial documents
- Assess patient level of trust in and comfort with the use of AI to generate patient-facing clinical trial documents
- Discuss the patient’s views on the importance of human review of AI-generated content and implications for the future