Regulatory Operations Blog - ERS Community

A forum created and managed by the Drug Information Association (DIA) Electronic Regulatory Submissions (ERS) community that provides best practices guidance on electronic submission issues and supports development of tools that will aid stakeholders in complying with and understanding the guidance, specifications, and regulations associated with regulatory submission issues. Specifically, the blog will focus on Regional requirements, eCTD 4.0/RPS, CDISC/ADAM/SEND, iCSRs/IDMP

Monday, June 22, 2015

FDA Electronic Submissions Presentations


DIA eRegulatory and Intelligence Annual Conference
Electronic Submissions Presentations
May 11-13, 2015, Philadelphia, PA

  • Electronic Submissions Update, Ginny Hussong, Director (Acting), Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • FDA Update: Submission of Promotional Materials, CDR Roberta Szydlo, RPh, MBA, RAC, Senior Regulatory Review Officer, Office of Prescription Drug Promotion, CDER
  • FDA’s Module 1 Update, Jared Lantzy, PMP, Division of Data Management Services & Solutions, Office of Business Informatics, CDER
  • eCTD IV Update, Mark Gray, Senior Project Manager, CBER


Posted by Adair Turner at 9:20:00 PM
Labels: Conferences, Presentations

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