Webinar · 30 June 2026
Submission-Ready in the DACH Region:
How to Avoid Delays and Unnecessary Costs
Live online
Free of charge
60 minutes
Date
30 June 2026
Time
13:00 – 14:00 CET
Format
Online webinar
Hosted by
Qmed Consulting
About the session
Germany, Austria, and Switzerland are often treated as a single regional submission pathway. They are not.

Each country has its own competent authority, its own ethics committee structure, and its own practical timelines. Treating DACH as one process is one of the most common reasons clinical investigation submissions stall — and it is almost always avoidable.

This webinar is built for teams preparing clinical investigation submissions in one or more DACH countries. We cover the country-specific requirements, common mistakes, and practical steps that separate a complete document set from a submission package that is actually ready to go out.

Join us on 30 June 2026 for a sixty-minute working session — practical, country-specific, and built around the questions teams actually run into.

Practical information

When

30 June 2026
13:00 – 14:00 CET

Where

Online
A link is sent before the session starts.

Price

Free of charge

Hosted by

Qmed Consulting
Copenhagen

Can't attend live? Register anyway — we'll send the recording.

What you will take away from this session.

What this webinar covers

  • How submission requirements and processes differ across Germany, Austria, and Switzerland
  • What submission-ready means in practice — and why a complete document set is not the same thing
  • The most common causes of avoidable delays in DACH submissions
  • Country-specific steps and authority processes that are frequently missed
  • What to check before your package goes out — not after
  • After this session you will be able to

  • Identify the country-specific requirements relevant to your submission pathway
  • Assess whether your submission package is ready, not just complete
  • Anticipate the most common pitfalls before they affect your timeline
  • Approach each DACH country with a clear picture of what the local process actually requires
  • Program — three sections, sixty minutes.

    13:00
    Section A

    Understanding the DACH Submission Landscape

    Before you can build a submission-ready package, you need to understand the environment you are submitting into. This section covers the regulatory foundations and country-specific structures that shape every clinical investigation submission in the DACH region.

    • Requirements
    • Practical Implementation
    • Country-Specific Requirements
    • Competent Authorities
    • Ethics Committees
    13:20
    Section B

    Building a Submission-Ready Package

    Having the documents is not the same as being ready to submit. This section focuses on what submission readiness actually looks like in practice — and what stops teams from getting there.

    • How to Become Submission-Ready
    • Pitfalls
    • Case Study
    13:40
    Section C

    Advanced Topics and Open Discussion

    For teams already familiar with the DACH submission process or preparing for more complex scenarios, this section covers two areas that frequently introduce uncertainty — and closes with open discussion.

    • EU EFS (European Filing System)
    • Notified Body
    • Q&A
    Speakers

    The hosts of this webinar

    Dr. Stephanie John

    VP of Clinical Affairs and Clinical Senior Principal Advisor

    Helene Quie

    Founder & CEO
    Reserve your seat

    Register for the session.

    One sixty-minute session, no cost, and the recording sent to your inbox afterwards. Add your details and we will hold a seat for you.

    Date

    30 June 2026

    Time

    13:00 – 14:00 CET

    Any questions? Reach out at

    Your details

    Qmed Consulting is a European Clinical Research Organisation and strategic partner for MedTech innovators — helping ideas become approved devices.

    info@qmed-consulting.com

    +45 56 64 10 10


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