Talk Outsourcing & Clinical Operations track
Winning the “Clinical Operations Super Bowl”: Regulatory inspections from a Clinical Operations perspective
Wed, Feb 12, 2025 · 10:00–10:30 AM PST Hyatt Regency San Francisco Airport
About this session
- Showcasing and defending the clinical operations strategy and outcome for pivotal studies during Sponsor regulatory inspections as the culmination of years of intense and important work; or the “Super Bowl” of Clinical Operations
- Sharing best practices based on real-life examples, for surviving and thriving during FDA and EMA Sponsor regulatory inspections from the Clinical Operations viewpoint
- Collaborating with QA and other cross-functional partners for success
- Best practices in logistics and Clin Ops teamwork in advance of, during and after the inspections
- Common, recent findings related to Clinical Operations during inspections
