EU - ASMF and adding new countries in established ASMFs as series with CA, USA, ZA

Drug substance manufacturers are often facing the situation to submit changes of their drug substance dossier to multiple authorities or the same changes for multiple dossiers for different customers.

EXTEDO invites you to its complimentary webinar "EU - ASMF (Active Substance Master File) and adding new countries in established ASMFs as series with CA, USA, ZA." 

In this webinar, we will give you a short introduction to Drug Master Files or Active Substance Master Files of different regions and will show you how the Core Dossier Concept of EXTEDO's DOCmanager can be used to generate submissions for multiple dossiers.

Following the presentation, our regulatory expert Frank Dickert (Senior Business Consultant) will answer your questions in the Q&A session.

Agenda  

• EXTEDO Company Introduction 
• EU - ASMF (Active Substance Master File)
• US FDA - DMF (Drug Master File)
• Health Canada - DMF
• South African SAHPRA - APIMF (API Master File)
• Core Dossier Concept of DOCmanager
• Q&A session