Title:
Training course on Building the eCTD: Practical Solutions to Compile Electronic Submissions
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
CANCELLATION POLICY
Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date.
Cancellations are subject to an administrative fee:
Full Meeting Cancellation:
Industry (Member/Non-member) = € 200.00
Government/Academia/Non-profit (Member/Non-member) = € 100.00
Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.
Transfer Policy
You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.
Event Code:
10545
Contact Information:
DIA Europe
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG
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