Winning the “Clinical Operations Super Bowl”: Regulatory inspections from a Clinical Operations perspective

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