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Wednesday, June 27 • 8:00am - 9:15am
#305: Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders

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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



Speakers
avatar for Mary Banach

Mary Banach

Project Manager CTSpedia, Vanderbilt University
Following a career in industry and academic clinical trials, Mary Banach currently leads two programs assisting in developing our understanding of risk in the clinical design process. The first program is a sub-group of the DIA Clinical Data Management group, called the DIA RBM Group... Read More →
avatar for Nimita Limaye

Nimita Limaye

Chief Executive Officer, Nymro Clinical Consultancy Services
She has worked across pharma/CROs for 20+ years, leading global RBM & CDM business. The past chair of SCDM, and on the steering committee of DIA India, Nimita has chaired 2 DIA RBM conferences & has presented on RBM in multiple forums. She provides consulting expertise and services... Read More →
avatar for Stephen Young

Stephen Young

Chief Operations Officer, CluePoints
As CluePoints COO, Steve is primarily responsible for ensuring successful customer adoption of the CluePoints platform. Steve worked for three bio-pharma companies over a span of 15 years where he assumed leadership positions in data management and led the successful enterprise roll-out... Read More →


Wednesday June 27, 2018 8:00am - 9:15am
Room 254AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA