Training Course for eCTD Submissions in Switzerland

Date(s) And Time(s):
Jun 16 2011 8:00AM - Jun 16 2011 5:30PM

Location:
Hotel Ambassador & Spa
Seftigenstrasse 99
3007 Bern
Switzerland

Overview:

Since January 2010, Swissmedic accepts electronic-only submissions in eCTD-format. This course will
offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD
submissions in Switzerland, and the eCTD review process. The focus will be on practical experience
gained in preparing and submitting eCTDs to Swissmedic.

Session 1 – eCTD Fundamentals

eCTD structure and XML backbone
Envelope information, meta data, and checksums
Submission ready documents and granularity
eCTD life cycle
Session 2 – eCTD Submissions in Switzerland

Swissmedic‘s experiences with eCTD submissions
Swiss specifications and guidelines
The Swiss Module 1 for eCTD

Session 3 – Case Studies

Applications according to §13 TPA
Baseline Submissions
Life cycle management with variations
Technical Correctness

Session 4 – Practical

eCTD creation and assembly
Hyperlinking and publishing process
eCTD life cycle
Key Topics

Basic information about the eCTD
Impact of the eCTD on regulatory processes and procedures
eCTD compilation and life cycle
Document granularity and readiness
Regulatory strategy facing technical issues
Swissmedics eCTD programme (staggered approach)
The use of the Swiss specifications and guidelines for eCTD
Preparation of the Swiss Module 1 for eCTD
Technical correctness of Swiss eCTDs
1:1 creation of a Swiss eCTD

Learning Objectives:

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

Understand the structure and the technical aspects of eCTDs
Prepare an eCTDs including “submission ready documents”
Be familiar with the Swiss requirements for eCTD submissions
Understand the processes and procedures of compiling and reviewing an eCTD
Support the transition from a paper process to an eCTD process
Describe technology used for eCTD compilation and review

Target Audience:

Professionals in:

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

Event Code:
11545

Contact Information:
DIA Europe
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

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