Concept↦Ethics and Laws↦Regulatory Advice↦Scientific Advice
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
- 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
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
Prior to a 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
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