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Drug Information Association Meeting to Discuss Framework and Future of Data Monitoring Committees

11/20/2012 2:51:01 PM

HORSHAM, PA — The DIA meeting, Data Monitoring Committees: Best Practices and Future Directions will be held November 29-30, in Washington, D.C., at the Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue NW. Meeting participants will discuss the evolving environment of Data Monitoring Committees (DMCs) and provide tools to navigate the changing pharmaceuticals data landscape. This meeting will explore the differing roles of DMCs and steering committees, and feature discussions on the capacities of DMCs for small and large companies. Participants will also discuss the proper role of DMCs within clinical trial infrastructure and the global nature of recruitment.

“As the role of DMCs evolves in the pharmaceutical environment, this meeting provides the essential groundwork for best practices for clinical trials as they move into a digital age,” said DIA Program Chairperson, Jonathan Seltzer, Applied Clinical Intelligence, LLC, President and CEO.

The first day theme will focus on “After a Decade of Guidance: Best Practices of Data Monitoring Committees” and the second day theme will focus on “The Future of Data Monitoring Committees in the World of Real Time Data and Risk Based Clinical Trials." The meeting will also feature a joint session entitled The Role of DMC in Adaptive Designs with the co-located meeting, DIA Adaptive Designs in Clinical Trials: Overcoming Persistent Barriers.

Sessions will include:

• After a Decade of Guidance: The Current Role of DMCs, moderated by Jonathan Seltzer, President and CEO, Applied Clinical Intelligence, LLC with a Reactor Panel including Dave DeMets, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin, Robert J. Temple, Deputy Director for Clinical Science, Center for Drug Evaluation and Research, Food and Drug Administration, and Robert M. Califf Vice Chancellor for Clinical Research, Duke University Medical Center; Director, Duke Translational Medicine Institute, United States

• Best Practices for Data Monitoring Committees moderated by Janet Wittes, President, Statistics Collaborative

• Data Monitoring Committees: After a Decade of the DMC Guidance, Where Do We Go From Here, with presentations by Robert J. Temple, Deputy Director for Clinical Science, Center for Drug Evaluation and Research, Food and Drug Administration; Robert T. O’Neill, Senior Statistical Advisor, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration; and Thomas R. Fleming, Professor of Biostatistics, School of Public Health, University of Washington.

Register for the DIA Data Monitoring Committees: Best Practices and Future Directions conference.

About DIA

DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. Follow DIA on Facebook, Twitter, LinkedIn, and YouTube. Stay updated on hot topic news at #druginfoassn on Twitter.

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