DIA Workshop on eCTD Compilation

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr...

Date(s) And Time(s):
Feb 17 2011 8:00AM - Feb 18 2011 4:00PM

Location:
Hotel Suba International
Plot No. 211 Chakala Sahar Road
Chakala, Andheri East
Mumbai 400099
India

Overview:

One-day Hands-on Workshop for Novices of eCTDs

During this interactive workshop you will compile a two-sequence
submission for a single country EU national procedure using
LORENZ DocuBridge®, as well as repurpose the EU compilation
for Switzerland. You will also examine common eCTD compilation
functionalities such as:
• Creating annotations and inter-document hyperlinks
• eCTD publishing
• eCTD validation

SPACE IS LIMITED TO 20 PEOPLE PER DAY

eCTD WORKSHOP AGENDA

9:00 INTRODUCTION

9:10 CREATING A SUBMISSION

9:30 ADMINISTRATIVE DATA: COMPILING REGIONAL MODULE 1

10:00 COMPILING CONTENT WITH ONE NODE TO ONE FILE RELATIONSHIPS

10:30 BREAK

10:45 COMPILING REPEATABLE CONTENT STRUCTURES

11:15 COMPILING CONTENT WITH ONE NODE TO MANY FILES RELATIONSHIPS

11:30 COMPILING MODULES 4 AND 5

12:00 CREATING ANNOTATIONS

12:10 CREATING HYPERLINKS

12:20 INITIAL SEQUENCE PUBLISHING

12:30 LUNCH

1:30 BASIC ECTD VALIDATION AND CORRECTING TECHNICAL ERRORS AND WARNING

1:45 LIFECYCLE MANAGEMENT: CREATE SEQUENCE 0001

2:30 DELTA PUBLISHING AND VALIDATION

2:45 BREAK

3:00 CLONING SUBMISSION SEQUENCE 0000 EU TO CREATE A SWISS SUBMISSION

3:30 CONCLUSION AND Q&A

Target Audience:
This workshop is open to people from pharmaceutical,
biotech, or CRO companies only.

Event Code:
11668

Contact Information:

Manoj Trivedi, Senior Consultant, Marketing & Program Development, DIA
(India) Private Limited; Cell: +91-9819777493
Fax: +91-22-2859-4762,
Email: Manoj.Trivedi@diaindia.org