Live Webinar
Construction of the European Drug Master File (EDMF) for Regulatory
Agencies
Overview:
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. A drug master file comprises two parts: the Applicant’s Part
(Open Part), which contains all the information that the license-
holder needs to assess the quality and submit a license or
amendment application; and the Restricted Part (Closed Part),
which contains confidential information about the manufacturing
procedure that only needs to be disclosed to the authorities. It
should be noted that DMF's may only be submitted in connection
with a licensing or amendment application or as part of a periodical
review procedure.
Areas Covered in the seminar:
l Examine the background and history with the EDMF
l Learn step-by-step how to construct and submit the EDMF (and
this is not FDA's DMF)
l DMF’s today are mostly prepared following the rules of Common
Technical Documentation (CTD)
l 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
l Expectations for Applicant's part and ASM Restricted Part of the
EDMF
l When to submit an EDMF? Who can submit an EDMF?
l Where and how to submit an EDMF? Are EDMFs to be approved
by the authorities, e.g., the Competent Authorities in Europe?
l Recordkeeping requirements and your responsibilities
l Combination medical device and drug manufacturers will also
benefit if you incorporate a medicinal product and how the
Competent Authority will assess your Master File
Click here to register for this webinar
Who Will Benefi