- Concept, Value, and Integration
- The Cost of Switching: SOP/Workflow Adjustments
- Continuous Process to Improve Accuracy
- About Taimei
Archives: Agenda
ROUNDTABLE SESSIONS
During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.
Roundtable 1
Mitigating risk in clinical supply chain
Pernille Hemmingsen, Chief Technology Officer, Adcendo
Roundtable 2
Engaging with CROs: defining deliverables and agreements
Asger Dahlgaard, VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S
Roundtable 3
Considering DCT trial design and impact on both the patient and company
John Zibert, Chief Medical Officer, Coegin Pharma
Transforming clinical trials: ideas from leading industry professionals
• Assessing outcomes from over 70 interviews with life science industry pioneers
• Reviewing what clinical professionals wish would be different in the life sciences industry
• Suggesting next steps towards further evolving clinical trials
Product handling activities in ATMP clinical trials: considerations and strategies for trial supplies
- Planning and scheduling considerations
- Understanding the requirements and importance of chain of identity and chain of custody within cell therapy trials
- Vetting critical partners and identifying technology tracking systems to assist with cell therapy supply
Cardiac Data Matters: Keeping Patients at the Heart of Innovation
Join an exclusive session with a market leader in continuous cardiac monitoring. Discover how to achieve unparalleled accuracy and patient compliance through cutting-edge, low-touch technology. Dive into the transformative power of AI and explore real-world applications that are reshaping cardiac care.
· Understand how continuous monitoring ensures precise data collection and enhances patient adherence and safety
· Uncover the revolutionary role of artificial intelligence in interpreting cardiac data
· Review practical examples and case studies demonstrating the effectiveness of continuous cardiac monitoring in clinical settings
End of conference
Building an Outsourcing Strategy for your clinical trials
• Initiation: landscaping and defining the project
• Strategy development: analyses and stakeholder management
• Implementation: selecting vendors, training and alignment
• Maintenance: KPIs and governance
• Tips and tricks to consider
Panel Discussion: Considering existing and emerging technology to assist with clinical trials
- Digitalization: what can we digitalize to improve systems and processes
- AI: what can we implement to save time and resource
- Systems: what technology and systems are available and emerging to assist in clinical trials and data management
Sharing latest updates to the Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS)
• Providing latest updates: what’s new from the EU regulatory framework?
• Learning from previous submissions: tips and tricks
Fireside Chat: How to de-risk a clinical development program?
- Value of obtaining early feedback from Key Opinion Leaders and Regulators
- Risk assessment at the trial level
- Trial oversight matrix implemented with all vendors and subcontractors