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Destigmatizing 483 Observations
Session Chair(s)
Erin Brown, MPH
Director, Industry Intelligence and Messaging
Association of Clinical Research Organizations (ACRO), United States
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 Objective : 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.
Speaker(s)
Panelist
David C. Burrow, JD, PHARMD
FDA, United States
Director, Office of Scientific Investigations, OC, CDER
Panelist
Cris McDavid, MS
Parexel International, United States
Senior Director, GCDO
Panelist
Nicole Stansbury
Premier Research, United States
Senior Vice President Global Clinical Operations
Panelist
Tracy Vanderslice
Gilead, United States
Vice President, Clinical Operations
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