What is it? Why is it important?

For Medicinal Products (MP) studies, the study SP-INV can request a scientific advice meeting with Swissmedic. Scientific advice meetings:

  • Usually take place:
    • During the conception or development phase of the study
    • Before the study application process
  • Are recommended in the event of:
    • Limited MP experience (e.g. 1st in human, phase I studies), and or
    • The intention is to seed an authorisation for the MP

The aim for the SP-INV is to obtain an evaluation by Swissmedic whether the:

  • The set-up of the study with its planned measures meet the prerequisites for a potential successful application
  • The overarching goal (e.g. regarding the aim of the study) is reachable, considering that both the scientific and regulatory requirements must be met

Discussions include:

  • The quality of the active pharmaceutical ingredient of the product (IMP) (e.g. with its expected effect on health)
  • The planning and organisation of pre-clinical and interventional studies
  • The pharmacovigilance and the risk management plan

More

Swissmedic recommendations are:

  • Binding and must be implemented by the SP-INV
  • Liable to costs. Scientific advice is not free of charge

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:

  • A meeting agenda with a list of questions and issues to discuss
  • A suggestion for potential meeting dates (e.g. within 4 to 8 weeks) and mode (e.g. in person, by TC)
  • List of attendees from the SP-INV team, including their respective functions (e.g. SP-INV, study manager, statistician)

As a SP-INV ensure you:

  • Are well prepared for the meeting. Swissmedic only discusses questions that were submitted prior to the meeting.
  • Submit changes to Swissmedic no later than 2 weeks before the meeting (e.g. adaptation of submitted questions)
  • Are aware that it is not the task of Swissmedic to develop your study protocol

More

Prior to a 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

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
  • MP – Medical Product
  • IMP – Investigational Medicinal Product
  • SP-INV – Sponsor Investigator
  • TC – Telephone Conference
Concept ↦ Ethics and Laws ↦ Regulatory Advice ↦ Scientific Advice
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 ↦ Scientific Advice

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