New and experienced regulatory staff are being encouraged to attend this symposium on how to submit an abridged application for a marketing authorisation. The event will be CPD-accredited and will cover how to avoid your application being invalidated. It will include information on:
how to compile a perfect dossier
how to prepare draft responses for clock-off
scientific advice meetings and their benefits
the new initial fees calculator
The event will also give an overview on generics, choosing a suitable reference product and knowing what’s expected from bio-equivalence studies.
You will have the opportunity to meet the expert speakers in break-out sessions.
Date and time
Tuesday 9 June 2015 9am to 4.30pm
1VS - The Westminster Conference Centre
1 Victoria Street, Westminster, London