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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>

Enforcement Update and Trends From a Global Perspective

Session Chair(s)

Barry  Berger, JD, MBA

Barry Berger, JD, MBA

Retired

Former Professor of Regulatory Affairs, Temple University, United States

This forum will address from an industry, regulator and public interest perspective some of the key current enforcement actions and trends. How can each group better address and respond to issues that present challenges to public health?

Learning Objective : Explain key global enforcement trends; Describe what could be done by industry or regulators to better address regulatory concerns going forward; Discuss the patient/public citizen perspective on what additional steps are needed in the future.

Speaker(s)

Cynthia  Schnedar, JD

FDA Point of View

Cynthia Schnedar, JD

Greenleaf Health Inc., United States

Principal, Regulatory Compliance

Douglas B. Farquhar, JD

Viewpoint on FDA Enforcement

Douglas B. Farquhar, JD

Hyman, Phelps & McNamara, PC, United States

Partner

Mitchell  Berger, JD, MPH, RAC

Clinical Trial Enforcement Trends

Mitchell Berger, JD, MPH, RAC

HHS, United States

Public Health Advisor

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