DIA 2018 Global Annual Meeting

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-626-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop will allow attendees to look at terms defined by regulatory authorities and to compare and contrast the understanding of risk-based monitoring (RBM) from the perspectives of the various stakeholders. We will use practical examples.

The DIA CDM and RBM Communities have been working on a project that creates a concrete ‘Roadmap’ for companies on how to implement ‘RBM’ - or more generally how to implement a data backbone in the organization that would allow the different functions (data management, pharmacovigilance, medical monitoring, operations, regulatory, etc.) to leverage the appropriate data collected/generated by CDM and other functions as indicators to identify critical risks in their specific area.

Learning Objectives

Define risk-based monitoring (RBM) from different stakeholders’ perspectives: data management, pharmacovigilance, medical monitoring, operations, and regulatory; Compare and contrast terms used in RBM from different stakeholders’ perspectives; Review the major difficulties encountered in each phase of developing an RBM program.

Chair

Mary Banach

Speaker

Where We Are: Where We Are Going
Stephen Young, MSc

Vendor Selection for Risk-Based Monitoring
Nimita Limaye, PhD