Your Easy Guide to Clinical Studies

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 (e.g. Ethics Committee (EC), Swissmedic submission)
• Are recommended in the event of:
  • Limited MP experience (e.g. 1st in human, phase I studies), and or
  • The intention is to seek market authorisation for the MP

 

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

• The set-up of the planned study meets the prerequisites for a successful Swissmedic 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 investigated MP (IMP) (e.g. expected health effects)
• The planning and organisation of pre-clinical and interventional studies
• The pharmacovigilance and the risk management plan

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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, data 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

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External Links

Swissmedic – see in particular

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