Building the eCTD: Practical Solutions to Compile Electronic Submissions

Venue: Ramada Plaza Basel

Location: Basel, France

Event Date/Time: Sep 23, 2010 End Date/Time: Sep 24, 2010
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Description

This course will offer insight into the compilation of the eCTD, share experience and best practise 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.

Key Topics:

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
NeeS and its role in eSubmission

Venue

Messeplatz 12
Basel
France
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