Scientific advice for development of medicines
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
- Pharmacovigilance and Risk Management
- The applicant submits the fill-out application form with the questions to scientificadvice basg.gvat
- 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 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.
For further information please contact
Daniela Gutschi, scientificadvicebasg.gvat, +43 (0) 50 555-36808
Created: 08.03.2009 | Page last modified: 20.06.2018