Regulatory & Quality Track

Clinical research leaders and teams will gain critical insights and proven best practices to uphold compliance, elevate quality, and ensure excellence in trial execution.

 
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Protecting Vulnerable Patients in Oncology Trials Through Optimized Informed Consent
The ABCs of IDEs: Making Sense of Regulatory Expectations for Investigational Device Exemptions
Starting Quality Assurance and Improvement Programs from the Ground Up
Trials in Transition: Navigating HHS Policy Shifts in 2025
Behind Closed Doors: The Inner Workings of Institutional Review Boards
Creating Sustainable and Efficient Clinical Research Compliance Programs
Aligned for Impact: Collaboration for FDA Inspection Readiness in Site Networks
Communicating Effectively with IRBs for Faster and More Robust Approvals
Implementation of an IRB Review Level Assessment Tool
How Much is Too Much?: Taking a Closer Look at the Ethics of Subject Compensation
The Ripple Effect: Making ICH E6(R3) Real Across Clinical Research
Beyond the Buzzwords: Oversight, Quality by Design, and Risk-Based Thinking
Better (Not) Call FDA: When and How to Flag Regulatory Oversight in Your Study