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Date(s) And Time(s):
Sep 23 2010 8:00AM - Sep 24 2010 5:30PM

Location:
Ramada Plaza Basel
Messeplatz 12
4058 Basel
Switzerland

Interest Area(s):
Regulatory Affairs, Medical Writing, Research & Development

Overview:

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

Learning Objectives:

At the conclusion of this course, participants should be able to:

Participate in the preparation of the eCTD including “submission ready documents”
Recognise EU requirements on a regional basis
Discuss the processes and procedures of compiling and reviewing an eCTD
Prepare sponsors to move from a paper to eCTD process
Describe technology used for eCTD compilation and review
Discuss the difference between eCTD and NeeS submission

Target Audience:

Professionals in:

Regulatory Affairs
Dossier Management
Document Management
Data Management
Compliance
Electronic Publishing/Submissions
IT/IS EDMS
Medical Writing

Event Code:
10545

Contact Information:
DIA Europe
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG