Drugs

Electronic Submissions Presentations

FDA/CDER Small Business and Industry Assistance (CDER SBIA) GDUFA and You Conference 2014
March 27, 2014

EDM and ERS/eCTD: Impact of e-Initiatives on Content and Context: FDA Update/Progress Report
December 5, 2013
 (PDF)

  • eCTD Update, Mark Gray, Director, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Quality and Product Data Standards, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • Study Data Standards Update, Ron Fitzmartin, PhD, MBA, Office of Strategic Programs, CDER
  • Top Ten Issues with Data, Douglas Warfield, Ph.D., Division of Data Management Services & Solutions, Office of Business Informatics, CDER
     

2013 GPhA/FDA ANDA Labeling Workshop / USP Forum
September 11, 2013

DIA EDM and ERS/eCTD Conference
October 9, 2012

DIA 2012 Annual Meeting
June 27, 2012, Philadelphia, PA

DIA Module 1 Townhall Webinar
February 9, 2012

DIA Electronic Submissions Conference
November 16-17, 2011, San Diego, CA

DIA Electronic Document Management
February 15-17, 2011, National Harbor, MD

DIA Electronic Submissions Conference,
October 28 - 29, 2010, San Diego, CA

DIA Annual Meeting,
June 14 – 17, 2010, Washington, DC 

GPhA/FDA Labeling Workshop,
April 14th, 2010, North Bethesda, MD
The 23rd Conference on Electronic Document Management, 
February 16th – 19th, 2010, National Harbor, MD
The 10th Conference on European Electronic Document Management,
December 4th – 5th, 2009, Vienna, Austria
The 8th Annual Electronic Submissions Conference “eCTD: The Adventure Continues”,
November 18th – 19th, 2009, San Diego, CA
The 45th DIA Annual Electronic Submissions Meeting, 
June 22nd – 25th, 2009, San Diego, CA
Strategic Management of CMC Dossiers in the eCTD Format,
March 10 -11, 2009, Baltimore, MD
The 22nd Conference on Electronic Document Management,
February 11th – 13th, 2009, Philadelphia, PA
DIA eCTD Conference,
November 2008, San Diego, CA
GPHA Technical Conference,
October 2008, Rockville, MD
DIA Electronic Document Management Meeting,
February 7, 2008, Philadelphia, PA

Please contact esub@fda.hhs.gov, if you have any questions about the presentations included on this page.

 

 

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