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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>

mHealth / mClinical and Clinical Trials: A Candid Discussion on Opportunities and Risks

Session Chair(s)

Philip  Coran

Philip Coran

Principal, Global Compliance and Strategy

Medidata Solutions, United States

This session will focus on the proliferation of mobile health (mHealth) and mClinical devices in the consumer and medical market and how these services may enhance clinical trials. The panel will cover perspectives from a variety of stakeholders including the FDA.

Learning Objective : Discuss the differences between mHealth and mClinical and clinical trial data; Identify how clinical trials can be enhanced by involving mHealth/mClinical data; Describe how to mitigate the risks to data integrity and subject privacy by using mHealth/mClinical services.

Speaker(s)

Craig  Lipset, MPH

mClinical/mHealth: Opportunities and Risks

Craig Lipset, MPH

Decentralized Trials & Research Alliance | Buffalo Initiative, United States

Co-Chair

Phillip D. Kronstein, MD

mClinical/mHealth: Regulatory Insights on Risks and Opportunities

Phillip D. Kronstein, MD

FDA, United States

Team Leader, Division of Clinical Compliance Evaluation, OSI, CDER

Julian M. Jenkins

mClinical/mHealth: Regulatory Insights on Risks and Opportunities

Julian M. Jenkins

Incyte Corporation, United States

Group Vice President, Development Operations and Project Management

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