Archives: Agenda

• 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.

• What is patient experience data collection and why does it matter?
• Mechanisms for patient engagement across the product development lifecycle
• Demonstrating the value of patient engagement from a variety of perspectives (i.e. biopharmaceutical, patient advocacy, regulatory, and payer)
• Understanding roles and responsibilities for patient advocacy organizations, patient opinion leaders, pharmaceutical sponsors, etc.

• Lessons learned in the Diagnostics space
• Use of eSystems data / information in Inspection Readiness
• Understanding the expectations of your Auditor (FDA vs. EU Notified Body)

• How early engagement can improve outcomes
• How do we speak the same language, no one size fits all approach
• Simplifying the complex in a world of overwhelming options and models

• How to implement
• Different approaches
• Interpretations
• Meaningful differences from ICH E6 R2

• Who needs to be risky? – vendor management team
• What tools are needed to manage risks?
• What qualification activities are needed? Less audits?
• How much oversight and management?