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DIA 8th Annual Electronic Submissions Conference Addresses Current Developments in eCTD around the World
Date:10/9/2009

>In addition, six concurrent pre-conference tutorials on November 17 will cover:

 
  • EU Regulatory Review Procedures and Their Implications for eSubmissions Publishing
  • INDs in eCTD Format
  • eCTD Basics
  • US-EU eCTDs (Creating eCTDs for the US and EU): Differences and Similarities
  • eCTD Lifecycle Management
  • Metadata and Standards: How Metadata Is Used from Protocol Definition to Regulatory Submission

The opening plenary sessions will feature speakers from FDA, the European Union, and Health Canada to present up-to-date information on FDA's standards, expectations, and experiences with eCTDs, as well as plans for eCTDs and eSubmissions in the US, EU, and Canada.

"Electronic CTD-formatted submissions have taken hold in the US and are on their way to doing the same in Europe," says Gary M. Gensinger, MBA, Deputy Director, Office of Business Process Support, CDER, FDA. "The 8th Annual Electronic Submissions Conference will discuss current developments in eCTD in the US and Europe, filing CTD-formatted submissions in other markets, and emerging technologies affecting electronic submissions."

Click here to register.

For exhibiting opportunities, contact Shannon Lewis at +1-215-442-6149 or Shannon.Lewis(at)diahome.org.

About the Drug Information Association (DIA)
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