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Training Course for eCTD Submissions in Switzerland

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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
Contact your regional office for future dates and locations.
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