National Scientific Advice

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
  • Biometry
  • Pharmacovigilance and Risk Management

 

Procedure

  • 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

 

Forms for scientific advice

Created: 08.03.2009 | Page last modified: 20.06.2018

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