What is it? Why is it important?
- The optimal strategy and how to optimise a submission
- Relevant administrative-, regulatory-, and legal issues
- 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.
- 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
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
Swissmedic – see in particular
- Human medicines / Authorisation / Information / Optimising authorisation-related meetings with applicants