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#637: Destigmatizing 483 Observations
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
117
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-627-L04-P; CME 1.00; RN 1.00

Hear from regulators and industry on the challenges and opportunities in supporting sponsors through 483 observations. Panelists will discuss their impact on monitoring strategies and the role that centralized monitoring plays in mitigating violations.

Learning Objectives

Discuss the impact of 483 observations on Risk-Based Quality Management (RBQM) strategies; Describe how perceptions about the criticality of 483 observations are influencing clinical monitoring strategy decisions; Identify opportunities to mitigate anxiety related to 483 observations and to support cohesion between sponsors, CROs, and regulatory agencies to enable future adoption of centralized monitoring strategies.

Chair

Erin Brown, MPH

Speaker

Panelist
Cris McDavid, MS

Panelist
Nicole Stansbury

Panelist
David C. Burrow, JD, PHARMD

Panelist
Tracy Vanderslice


Speakers
avatar for Erin Brown

Erin Brown

Director, Industry Intelligence and Messaging, Association of Clinical Research Organizations (ACRO), United States
Erin Brown is the Director of Industry Intelligence and Messaging for the Association of Clinical Research Organizations (ACRO), where she leads survey development, collection, and analysis related to risk-based quality management (RBQM) adoption, FDA regulatory trends, and other... Read More →
avatar for David Burrow

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA, United States
David Burrow is the Director of the Office of Scientific Investigations (OSI) within the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). He leads CDER's Bioresearch Monitoring (BIMO) program, overseeing clinical... Read More →
avatar for Cris McDavid

Cris McDavid

Senior Director, GCDO, Parexel International, United States
Cris McDavid is a seasoned clinical research leader with over 20 years of global clinical trial delivery experience. Cris leads Parexel Risk-Based Quality Management (RBQM) operations and Integrated Data Delivery (IDD), driving strategic process and technology implementation across... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States
Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →
avatar for Tracy Vanderslice

Tracy Vanderslice

Vice President, Clinical Operations, Gilead Sciences, United States
Wednesday June 17, 2026 1:45pm - 2:45pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

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