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Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Session Chair(s)
Brian Edwards, DrMed
Vice President
International Society of Pharmacovigilance, United Kingdom
This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.
Learning Objective : Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.
Speaker(s)
Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Vice President
Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS
Janssen Research and Development, LLC, United States
Medical Safety Officer
Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc
Healthcare Safety Investigation Branch, United Kingdom
National Investigator
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