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Omni Shoreham Hotel

22 sep 2014 8:30 a.m. - 24 sep 2014 1:00 p.m.

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

EDM and ERS 2014

Session Chair(s)

Gary M. Gensinger, MBA

Gary M. Gensinger, MBA

Senior Advisor for Records, OSP, OBI, CDER

FDA, United States

Speaker(s)

Mark A. Gray

CDER eCTD Update

Mark A. Gray

FDA, United States

Senior Project Manager, DSB, CBER

Ron  Fitzmartin, PHD, MBA

Moving Toward Required Study Data Standards, A Regulatory Update

Ron Fitzmartin, PHD, MBA

Decision Analytics, United States

Principal Consultant

Vada  Perkins, DRSC, MSC

Identification of Medicinal Products (IDMP): Update on Technical Specifications, Maintenance, and Implementation Activities

Vada Perkins, DRSC, MSC

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

Paul M. Loebach

Paul M. Loebach

FDA , United States

Team Leader, Drug Registration and Listing Program, OC, CDER

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