Four Seasons

We’re excited to announce that our very own Nik Burlew will be speaking at this year’s Regulatory Symposium on Thursday, August 22nd in Denver. This half day symposium focuses on current regulatory issues including site audits, product approvals, software regulations and more. To learn more or register, visit the Regulatory Symposium website.

Good luck, Nik!!


FDA Denver District Office Update
Devin Koontz, Public Affairs Specialist, FDA

Communicating with the FDA – Real-World Experiences from Site Audits to Product Approvals and Clearance Negotiations
Speakers: Nikolas Burlew, VP of GxP/CMC Quality Assurance, Clinipace
Catherine Bens, Integrated Quality Management, Colorado State University
Moderator: Jason Sapsin, Polsinelli

Software Regulation and Validation
Jim Rosa, VP of Quality Engineering Systems & Software, Reglera