Name: FDA UPDATE: OVERSIGHT OF CLINICAL TRIAL TRANSPARENCY
Start: 2024-10-15T11:10:00-0700
End: 2024-10-15T12:10:00-0700

Tuesday October 15, 2024 11:10am - 12:10pm PDT

Understand the Legal Transparency Expectations and Obligations, the FDA’s Risk-Based Approach to Oversight, and the Process for Noncompliance

Discuss the drive behind FDA’s commitment to ensure a complete record of interventional clinical trials is available
Detail clinical data disclosure requirements and expectations
Breakdown the FDA’s risk-based approach to prioritize compliance and enforcement actions for violations
Walk through the pre-notification process, timeline for action and potential consequences if none occurs

Tuesday October 15, 2024 11:10am - 12:10pm PDT

2nd annual Clinical Data Disclosure and Transparency Summit