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- Clinical Standards Draft Guidance on Data Standardization Planning (CBER/CDER/CDRH)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.”
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.
Contact: Mike Keller
DIA
Phone: +1 215.442.6173
Mike.Keller@diahome.org