What is it? Why is it important?

The study SP-INV can request a pre-submission meeting with Swissmedic. Aim of the meeting is to discuss and resolve questions related to a planned study.

In general, these meetings address questions related to:

  • The optimal strategy and how to optimise submission
  • Administrative-, regulatory-, and legal issues addressing submission aspects of the study application

The meeting:

  • Does not evaluate the expected content of an application
  • Is not binding
  • Is liable to costs

Swissmedic only discusses questions that were submitted prior to the meeting.

In the event questions cannot be resolved during the meeting, Swissmedic will follow-up with a written statement.

What do I need to do?

As a SP-INV, submit an application for a joint meeting to Swissmedic. Include the following information:

  • List of questions and issues to discuss (e.g. draft an agenda)
  • Suggested meeting dates (e.g. within 4 to 8 weeks) and mode (e.g. in person, by TC)
  • List of attendees and their respective functions (e.g. SP-INV, study manager, statistician)

Modification or changes are only allowed up until two weeks before the meeting.

Prior to the meeting, Swissmedic accepts the application and confirms a date.

The meeting:

  • Duration must not exceed 1h30
  • Swissmedic chairs the meeting
  • Only pre-defined questions are discussed
  • Keep explanations short and to the point.
  • Be confident in questions you seek an answer to
  • Take meeting notes and include decisions taken
  • Submit minutes to Swissmedic for approval

More

You can still forward, up until 2 weeks before the meeting, any changes to Swissmedic (e.g. organisational aspects, submitted questions).

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissmedic – see in particular

  • Human medicines / Authorisation / Information / Optimising authorisation-related meetings with applicants
Abbreviations
  • CTU – Clinical Trials Unit
  • SP-INV – Sponsor Investigator
  • TC – Telephone Conference
Concept ↦ Ethics and Laws ↦ Regulatory Advice ↦ Pre-Submission
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Regulatory Advice ↦ Pre-Submission

Please note: the Easy-GCS tool is currently under construction.