Construction of the European Drug Master File webinar by Compliance4all

Construction of the European Drug Master File webinar by Compliance4all


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About The Event

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
Regulatory Affairs
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Engineering/Technical Services/Operations

Speaker Profile:
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.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Event Link :
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