Listen to the Recorded Webinar: "Adapting a US eCTD for Submission in other ICH Regions"

CanReg and EXTEDO held a webinar entitled "Adapting a US eCTD for Submission in Other ICH Regions"

Life Sciences companies wishing to gain product approval in more than one ICH region can gain significant time and cost advantage by creating a single master dossier targeted toward one region and then adapting it to meet the needs of other ICH regions.

Expertise and resources can be centralized and optimized. A "build once and re-use" strategy will improve the consistency and quality of submission documents. This presentation will outline the essential regional differences, in both an electronic and paper context, to be considered when building a master dossier that will meet regulatory requirements across ICH regions.

Featured Speakers:

Harv Martens, VP Operations, North America and Japan, EXTEDO Inc.
Elizabeth Wishart, Director, Quebec Business Unit, CanReg Inc.

Listen to the recorded Webinar:

https://www2.gotomeeting.com/register/383106371