Hyatt Regency Denver Anschutz Medical Campus
13200 E. 14th Place
Aurora, CO 80011
Event Description:
This Year’s Theme: Quality by Design: Building Better Clinical Trials
Quality doesn't happen by chance. Join us as leading experts explore how Quality by Design is reshaping the way we design, conduct, and oversee clinical trials.
Inspired by the global ACRP conference, this event brings top-tier education and thought leadership directly to Colorado. We are honored to welcome four distinguished speakers—all seasoned presenters at the global conference—who will share their expertise and perspectives with our local research community.
Whether you work in academia, industry, or at the front lines of clinical trial coordination, this summit offers a unique opportunity to deepen your knowledge, engage in meaningful discussion, and connect with peers across the Rocky Mountain research community.
Speakers:
David Vulcano, MSW, MBA, CIP, RAC, FACRP
Chief Executive Officer
Association of Clinical Research Professionals (ACRP)
(Opening Remarks provided virtually)
David Burrow, Pharm.D., J.D.
Director, Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration
(Speaker will appear virtually)
Kenneth Getz
Executive Director and Professor
Tufts Center for the Study of Drug Development
Tufts University School of Medicine
Leslie Sam
President, Leslie Sam and Associates, LLC
Glenda Guest, RQAP-GCP
President and Founder
Assured of Quality Consulting & Training
Flagstaff, AZ
Learning Objectives:
- Describe the principles of Quality by Design (QbD) and explain how current regulatory expectations are shifting from detecting quality issues to proactively designing quality into clinical trials.
- Identify protocol design factors that contribute to operational inefficiencies, increased site and participant burden, recruitment challenges, and downstream quality risks.
- Discuss practical strategies for integrating Quality by Design principles into study planning, startup, and cross-functional clinical trial operations.
- Recognize common inspection findings and quality deficiencies that can be traced to decisions made during protocol development and study execution, and identify approaches to reducing these risks.
- Integrate regulatory, protocol design, operational, and inspection perspectives to develop a more proactive, systems-based approach to building quality into clinical trials.
Registration Information:
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Price Point
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Early Bird Registration
(July 17, 2026 – August 31, 2026)
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Regular Registration
(September 1, 2026 – October 23, 2026)
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Chapter Member
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$100
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$125
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ACRP Member
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$125
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$150
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Non-Member
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$150
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$175
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Group Rate (10+ registrants)
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$125
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$125
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Groups of 10+ registrants can receive a flat rate of $125 per person. Contact laurie.burnside@outlook.com for additional information.
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
The educational portion of this event may be self-reported as 5 points toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.