Archives: Agenda

• Sustaining community outreach and engagement through CISCRP’s Journey to Better Health Mobile Unit
• The impact on perceptions and behaviors with regards to clinical research
• Partnering with community educators, drawing attention to the need to be aware of clinical research

• 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.

• 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

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