National Scientific Advice

National Scientific Advice (NASA)

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

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 scientificadviceagesat
• The validation of the application is performed within four working days.
• The applicant recives 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 for Marketing Authorisation & Lifecycle Management.
• 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 for Marketing Authorisation & Lifecycle Management.
• The draft meeting minutes are finalised by the BASG and transmitted to the applicant.
• The provided scientific advice is non binding for the applicant.