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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

Who should attend?

Professionals in:

  • Regulatory Affairs
  • Dossier Management
  • Document Management
  • Data Management
  • Compliance
  • Electronic Publishing/Submissions
  • Medical Writing
  • Project Management
  • Quality



Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date.
Cancellations are subject to an administrative fee:
Full Meeting Cancellation:

Industry (Member/Non-member) = € 200.00
Government/Academia/Non-profit (Member/Non-member) = € 100.00

Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.

Transfer Policy

You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.


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

Contact us

DIA Europe


4002 BASEL



TEL.: +41 61 225 51 51

FAX:  +41 61 225 51 52