Training Course for eCTD - Submissions in Switzerland

Date(s) And Time(s):
Dec 8 2011 9:00AM - Dec 8 2011 5:00PM

Location:
Hotel Courtyard by Marriott Zurich North
Max-Bill-Platz 19
8050 Zurich
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

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:

Who Will Attend

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

Event Code:
11590

Contact Information:
DIA EUROPE
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG

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