This combined EDM and ERS/eCTD meeting will review the entire sequence from authoring to submission delivery and maintenance well as crucial industry topics such as PDUFA V eData Standards and eSubmissions & the TMF Model and Implications. DIA brings these two meetings together to emphasize the strong EDM and ERS relationship to offer total clarity on standards/procedures and central subject matter to industry professionals. This meeting will be held October 9-11 in Baltimore, MD with preconference tutorials on October 8.
Don’t miss these hot sessions:
• FDA Update/eCTD Progress Report
• PDUFA V eData Standards and eSubmissions
• TMF 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• Clinical Standards Draft Guidance on Data Standardization Planning (CBER/CDER/CDRH)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. How is that done anyhow?
• Moving to Content Management & Authoring: Steps for Change
• CDISC SEND: Implementing Standardized Non-clinical Data in Submissions
• "What the Future Holds" Implementing Process & Technology to be ready to Electronically Submit 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 Paul Pomerantz, DIA Worldwide Executive Director. “DIA seeks to deliver the most informative and engaging content to its attendees and this conference is no exception.”
Register for EDM and ERS/eCTD: The Content Continuum from Document Authoring through Submission Delivery here.
Follow the conversion on Twitter at #DIAESUBS.
ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices and related medical products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; and Beijing, China. www.diahome.org. Follow DIA on Facebook, Twitter, LinkedIn, and YouTube. Stay updated on hot topic news at #druginfoassn on Twitter.
