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DIA EDM and ERS/eCTD Conference Reviews eSubmissions and PDUFA V eData Standards

Horsham, PA — Sep 07, 2012

DIA will host EDM and ERS/eCTD: The Content Continuum from Document Authoring through Submission Delivery from October 8-10 in Washington, DC. This combined EDM and ERS/eCTD meeting will review the entire sequence from authoring to submission delivery and maintenance as well as crucial industry topics such as PDUFA V eData Standards and eSubmissions and the TMF Reference Model and Implications. Sessions will include:

  • FDA Update/eCTD Progress Report
  • PDUFA V eData Standards and eSubmissions
  • TMF Reference Model and Implications
  • Clinical Standards Draft Guidance on Data Standardization Planning (CBER/CDER/CDRH)
  • The “Cloud” for the Benefit of the Content Continuum from Document Authoring through Submission Delivery 
  • Moving to Content Management & Authoring: Steps for Change
  • CDISC SEND: Implementing Standardized Non-clinical Data in Submissions
  • Implementing Process & Technology for Electronic Submission of Advertising & Promotional Material
  • Successful Practices for Sponsor Collaborations

“This meeting seeks to bring together professionals in ERS and EDM to fully demonstrate the scope of the document process and discuss vital industry issues. The mix of informative presentations, instructive tutorials, and dynamic symposiums along with an interactive exhibit hall with agency personnel, speakers and colleagues will prove to be most beneficial to professionals in EDM and ERS,” says DIA Worldwide Executive Director Paul Pomerantz. “DIA seeks to deliver the most informative and engaging content to its attendees and this conference is no exception.”


 

 

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.

Contact: Mike Keller
DIA
Phone: +1 215.442.6173
Mike.Keller@diahome.org