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Walter E. Washington Convention Center

2015 年 06 月 14 日 2:30 下午 - 2015 年 06 月 18 日 6:45 下午

801 Mount Vernon Place, NW, , Washington, DC 20001-3614 , USA

DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

Full conference and one-day registrants will have access to presentation PDFs through Friday, December 18, 2015 <A href="http://www.diaglobal.org/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/ePac-Presentations-Access.aspx">Review Presentations </A>

Implementing Risk-Based Monitoring: Best Practices from Pharmaceutical Industries to Contract Research Organizations

Session Chair(s)

Warren H. Pence

Warren H. Pence

Associate Director, Adaptive and Intelligent Monitoring

PPD, Inc, United States

This session will provide attendees with practical and useful “take-home” information and best practices that can be used by their organizations in the development and implementation of a risk-based monitoring (RBM) strategy.

Learning Objective : Describe management of study risk at a holistic level including management of study risk through ongoing site quality assessments; Incorporate remote monitoring methods using best practices in a risk-based monitoring (RBM) strategy, taking challenges into account; Apply best practices and tools to aid sponsor-contract research organization collaborations in implementation of RBM.

Speaker(s)

Mary  Arnould, BSN, MSN

Implementation of Off-Site Monitoring: Successes and Challenges

Mary Arnould, BSN, MSN

Astellas, United States

Director, Clinical Science Operations

Peggy  Zavala, MHA

Elements of Successful Partnering to Execute RBM: A Biopharmaceutical Company Perspective

Peggy Zavala, MHA

Celgene Corporation, United States

Associate Director, Clinical Monitoring-Americas

Warren H. Pence

Managing Study Risk Through Site Health/Quality

Warren H. Pence

PPD, Inc, United States

Associate Director, Adaptive and Intelligent Monitoring

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