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New Health Canada Requirements for Filing Drug Master Files in Electronic Format

March 17, 2016 @ 10:00 - 11:00 UTC+0



This archived webinar recording, upon full review, can grant you 1 Credit towards your RAPS RAC recertification.

Please enjoy the archived recording of this webinar.


Webinar Topic:

New Health Canada Requirements for Filing Drug Master Files in Electronic Format

Webinar Date/Time:

Thursday, March 17, 2016 at

10:00 am est (NYC, USA)

3:00 pm bst (London, UK)

4:00 pm cest (Paris, FR)

Webinar Host:

ted hanebach

Ted Hanebach

Director of Regulatory Operations, Mapi Group

Webinar Description:

On October 5, 2015, Health Canada posted the Notice Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format. This notice announced that, effective immediately, new DMFs transactions related to existing DMFs, and DMF updates should be provided in "non-eCTD electronic-only" format. In addition, Health Canada has provided deadlines of January 1, 2016 as the date at which paper copies of DMF transactions are no longer acceptable, and March 31, 2016 as the date by which all existing DMFs in paper format must be fully converted into the “non-eCTD electronic-only” format.

This Webinar will analyze the requirements from the updated HC guidance on filing DMFs in non-eCTD electronic regulatory activities, and will discuss the best submission preparation practices for filing DMFs in non-eCTD and eCTD filing formats.

** Register to attend this webinar now: **


** FAQ **

Will the webinar's slides be posted online after the live event?

After March 17, 2016, you may view the recorded webinar slides on Mapi Group's website upon logging in with your free mapigroup.com member credentials (if not already acquired, you may register for free on our website anytime): https://mapigroup.com/eventscalendar/new-health-canada-requirements-for-filing-drug-master-files-in-electronic-format/.