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Omni Shoreham Hotel

Sep 22, 2014 8:30 AM - Sep 24, 2014 1:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

EDM and ERS 2014

Closing Plenary - "Ask the Regulators" Session

Session Chair(s)

Gary M. Gensinger, MBA

Gary M. Gensinger, MBA

Senior Advisor for Records, OSP, OBI, CDER

FDA, United States

Closing Plenary - "Ask the Regulators" Session

Speaker(s)

Mark A. Gray

Panelist

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

Ginny  Hussong

Panelist

Ginny Hussong

FDA, United States

Branch Chief, Data Standards, CBER

Ron  Fitzmartin, PhD, MBA

Panelist

Ron Fitzmartin, PhD, MBA

FDA, United States

Senior Informatics Advisor, Office of Regulatory Operations, CBER

Additional FDA Speakers  Invited

Additional FDA Speakers Invited

United States

Pieter  Vankeerberghen

Panelist

Pieter Vankeerberghen

European Medicines Agency, Netherlands

Head of Clinical Trials

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