There’s nothing like getting backup from the U.S. Food and Drug Administration (FDA) during a debate with your boss. Just ask popular ACRP conference speaker David Burrow, PharmD, JD, director of the FDA’s Office of Scientific Investigations within the Office of Compliance for the Center for Drug Evaluation and Research.
“Some of the most rewarding comments I’ve gotten are that when [attendees] hear me speak about the development in clinical research and the way that I see certain things, it is empowering for the ACRP [audience member] and validation that the way that they think about these issues is correct,” Burrow says. “They take this information and say, ‘That’s exactly what I told my supervisor.’”
The direct dialogue between the agency and front-line clinical trial practitioners is invaluable, Burrow adds. “I think being able to come to these types of events and hear from FDA that what they’re doing and the way that they’re acting and seeing development in industry is appropriate…empowers them to be able to raise the bar in clinical research within their own practices.”
The clinical trial universe is in a state of sometimes dizzying flux. “We talk about things that change all the time—change in study design, change in the way that professionals conduct clinical research, change in the way that we train our workforce,” Burrow says. “I think professional development and continued education like what ACRP provides is essential to being a responsible steward for the industry.”
Hear Directly from FDA Officials at ACRP 2019
Officials from U.S. Food and Drug Administration will be at ACRP 2019 next month to discuss everything from medical device initiatives at the agency to inspection compliance, regulatory trends, and the future of clinical trials. Check out these FDA-led sessions and sign up today to be in Nashville April 12-15, 2019 for the premier education and networking event for clinical research professionals.
FDA Officials to present:
The Future of Clinical Research: Where We Are Heading and What It Means to You
CDER BIMO Compliance and Enforcement: What You Need to Know
Advancing Medical Device Innovation and Safety: An FDA Perspective
Office of Regulatory Affairs Update
Knock, Knock… FDA is Here: Be Prepared for a Regulatory Inspection
It’s never been more important for clinical trial leaders to work toward a better kind of future. Burrow challenges those in the industry to “ask ourselves how might this industry change over time? How might my work change? And how might I, myself as a professional, change because of that?” The questions aren’t easy, he acknowledges. “They might not have concrete answers, but that doesn’t make them any less valuable for us to sit down and try to forecast together with an open mind.”
For the ACRP 2019 gathering in Nashville in April, Burrow is speaking as part of a panel and in a standalone session. He tries to encourage open-ended, creative thinking at each encounter. “My approach here is to come in with an open mind, and to take my compliance hat off, and just to be able to engage in a conversation about what might be. I find that ACRP and this conference is an exceptional way to get FDA’s message out to an incredibly broad, diverse, and deep cross-section of industry.”
Author: Michael Causey
