Hotel Courtyard Marriott Zurich, Zurich, Switzerland
Dec 8 2011 9:00AM - 5:00PM
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 Event Code:
11590
|
|