Your Easy Guide to Clinical Studies

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

• The optimal strategy and how to optimise a submission
• Relevant administrative-, regulatory-, and legal issues 

 

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.

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

Mehr

External Links

Swissmedic – see in particular

• Human medicines / Authorisation / Information / Optimising authorisation-related meetings with applicants