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Building the eCTD

  June 06, 2008  
Drug Information Association, Dorint Praha Don Giovanni Hotel, Vinohradska 157a, Prague, Czech Republic
Sep 8 2008

This course will offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on practical experience gained in preparing and submitting electronically. Highlights: • Overview of eCTD readiness at the agencies • Impact of the eCTD on regulatory processes and procedures • Practical experience of submitting an eCTD in the EU • eCTD compilation and life cycle • Document granularity and readiness • Regulatory strategy facing technical issues   • Specifications and standards versus regions and procedures.
Organized by: Drug Information Association
Invited Speakers: Olaf Schoepke, PhDManaging DirectorExtedo Ltd.United Kingdom.
Deadline for Abstracts: Sep 8 2008
Registration: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16832&eventType=Training Course
E-mail: talana.bertschi@diaeurope.org
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