Strategic Advice - Direct from FDA Personnel

Officials from U.S. Food and Drug Administration will discuss everything from medical device initiatives at the agency to inspection compliance, regulatory trends, and the future of clinical trials.

Don't miss these FDA-led sessions and all the valuable discussion at these dynamic sessions:

The Future of Clinical Research: Where We Are Heading and What It Means to You

Get a multi-stakeholder view into the future of clinical research. Featuring FDA’s Burrow as well as:

  • TransCelerate Biopharma, Inc.

  • Parexel International

  • PCRS Network, LLC

Monday, April 15 — 8:00-9:00 am

Session Details >>

David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


Knock, Knock… FDA is Here: Be Prepared for a Regulatory Inspection

What do you do when a regulatory agency knocks on the door? Join Eric Pitman from FDA’s Office of Regulatory Affairs and explore ways to ensure you’re prepped for the inevitable “knock.” An inspection should be an exercise to ensure your systems are working the way you designed them. Make it one.

Saturday, April 13 — 10:15-11:15 am

Session Details >>

Eric Pittman, Program Division Director, FDA , Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

Eric Pittman, Program Division Director, FDA , Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs


David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

CDER BIMO Compliance and Enforcement: What You Need to Know

Back by Popular Demand! FDA's David Burrow will discuss key opportunities to make your FDA inspection experience a positive one. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.

Monday, April 15 — 10:15-11:15 am

Session Details >>


EFS is the New OUS Strategy for Early-Phased Medical Device Clinical Trials

Get real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions.

Saturday, April 13 — 10:15-11:15 am

Session Details >>

Maureen Dreher, PhD, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health (CDRH)

Maureen Dreher, PhD, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health (CDRH)


Office of Regulatory Affairs Update

FDA's Chrissy Cochran, PhD, Director, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, will detail ORA's “Program Alignment” initiative, including new divisions, what the initiative will mean for your next (or first) inspection, who to contact with concerns, and much more.

Sunday, April 14 — 3:15-4:15 pm

Session Details >>

Chrissy Cochran, PhD, Director, FDA Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

Chrissy Cochran, PhD, Director, FDA Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs


Advancing Medical Device Innovation and Safety: An FDA Perspective

Maureen Dreher, PhD, of FDA's Center for Devices & Radiological Health (CDRH) will offer insight into CDRH initiatives across the total product lifecycle, ranging from streamlined regulatory approaches for clinical studies, to new programs for expediting review of devices which address unmet medical needs.

Sunday, April 14 — 10:15-11:15 am

Session Details >>

Maureen Dreher, PhD, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health (CDRH)

Maureen Dreher, PhD, Policy Analyst, Clinical Trials Program, US Food and Drug Administration, Center for Devices & Radiological Health (CDRH)