Recording from Wednesday, July 18, 2018

IPEC-Americas has published the first revision of their U.S. Drug Master File Guide for Pharmaceutical Excipients. The revised voluntary guide offers best practices related to submission of an excipient drug master file utilizing the ICH Common Technical Document (CTD) format. The session will cover the guide's revisions and updated material.

Learning Objectives
> Reason(s) for excipient DMF
> Content and level of information for excipient DMF (based on excipient type)
> Regulatory requirements, if any, that apply
> Process for filing a U.S. excipient DMF
> Electronic filing requirements
> IPEC’s collaboration with FDA
> Excipient dossier requirements in other regions (China, Japan, Canada)