Archives: Agenda

The session will look at:

• The impact of wastage in clinical supply chains
• Key aspects of savings and efficiency brought by accurate supply forecasting in clinical trials
• The promise of AI and what it really means
• The RTSM ecosystem and how supply forecasting fits
• What supply managers and sponsors need to look for when considering this

• Commercially Available Medications and Ancillary Supplies
• Optimizes Capital and Employee Effort
• Minimizes Waste and Risk
• Provides Significant Savings
• Sustainably Friendly

• Reviewing where supply chain and QP documentation is impacted
• Labelling requirements for IMP
• Sharing supply chain challenges and benefits experienced so far under CTR

• Introducing design principles to support sustainability and circularity
• Discussing roadmap considerations
• Utilizing best practices from other industries
• Exploring the advantages of an end-to-end solution

• Strategic sourcing and supplier management
• Inventory management, technology and automation
• Regulatory readiness
• Risk management framework
• Solutions / considerations / cost efficiency

• Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
• Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
• Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
• Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

• Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
• Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
• Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
• Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

• Changing foreign relations priorities in US
• History of the US BioSecure Act, its future, and potential impact on the Pharmaceutical Industry
• US pharma industry reliance on foreign CROs and CDMOs to advance research
• Risk assessment for companies with ongoing drug development activities with a foreign CRO/CDMO

The evolving regulatory landscape following the Trump administration has introduced significant changes that continue to affect clinical trials. This session will explore the lasting impact of policy shifts on trial design, patient recruitment, and data transparency. Industry experts will discuss key regulatory updates, including FDA guidance changes, supply chain implications, and funding adjustments. Attendees are welcome to interact and discuss how these developments are shaping clinical research strategies and what steps organizations can take to ensure compliance and operational efficiency in this new environment.