Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure.
Confidential information from the manufacturer must be protected. However, at the same time the license-holder must receive all the information it needs in order to takeresponsibility for the quality of a medicinal product.
Areas Covered in the Session:
Examine the background and history with the EDMF
Learn step-by-step how to construct and submit the EDMF (and this is not FDA's DMF)
DMF's today are mostly prepared following the rules of Common Technical Documentation (CTD)
Understand that this is a document containing the information required to demonstrate that the quality of the active substance is adequately controlled by the specification proposed by the applicant
Expectations for Applicant's part and ASM Restricted Part of the EDMF
Who will benefit:
This webinar will provide valuable assistance and guidance to manufacturers who must prepare and submit the Drug Master File (Active Substance Master File) to European Competent Authorities. Employees who will benefit include:
All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the EDMF process and expectations
Quality and Compliance
Marketing & Sales
David Dills , Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape.
Compliance4All DBA NetZealous,
Event Link : http://www.compliance4all.com/control/w_product/~product_id=500840LIVE?channel=mailer&camp=webinar&AdGroup=eventsinamerica_Dec_2016_SEO
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