Recent public health concerns, governmental shifts in funding priorities, and international trade and commerce discussions have made clinical research more visible now than ever before. As a result the clinical trial enterprise is rethinking everything from trial design to technology to enrollment to finances. Staying ahead of the evolving expectations for clinical research is critical in ensuring compliance but more importantly ensuring excellence in translating clinical trial findings into improved public health. In this talk, the presenter will review key areas of regulatory updates and take a deeper dive into the thinking of the regulatory bodies which is guiding this evolution. The presenter will summarize the regulatory updates while engaging the learners in an actionable plan moving forward.

Upon completion of this presentation, learners should be able to:

• Discuss the impact of the current administration’s approach and philosophy around policy and resources on clinical research 
• Analyze the latest information on the revised GCP - ICH E6 (R3) guidelines and summary of the FDA Diversity Action Plans
• Outline the strategy for a re-envisioned and sustainable clinical research enterprise moving forward