The objective of such national scientific advices is to discuss with BASG scientific matters regarding the development of medicines.

In general, scientific advices are held as online meetings, which will be hosted and organised by the BASG. Alternatively, a face to face meeting or written scientific advices can be selected by the applicant as the preferred format.

Applicants have the opportunitiy to obtain input to questions addressing the following topics:

• Quality of Medicines
• Pre-clinical studies
• Clinical trials
• Biometry
• Pharmacovigilance and Risk Management

Procedure

• The applicant submits the fill-out application form with the questions to scientificadvice @basg.gv.at
• The validation of the application is performed within four working days.
• The applicant receives a document of agreement with an estimate of costs for the procedure and a proposed date for the meeting.
• This document also contains the final date to submit the information relevant for the assessment (dossier) to the Institute Assessment & Analysis.
• This date is usally set at three weeks prior to the date of the meeting.
• After the meeting the applicant submits draft meeting minutes to the Institute Assessment & Analysis.
• The draft meeting minutes are finalised by the BASG and transmitted to the applicant.
• The provided scientific advice is non binding for the applicant.