Preparation and Submission of Drug Master Files (DMFs)

Venue: Holiday Inn

Location: Somerville, Mass., United States

Event Date/Time: May 28, 2009 End Date/Time: May 29, 2009
Registration Date: May 28, 2009
Early Registration Date: May 28, 2009
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A Two-day comprehensive and interactive course, workshops, and case studies on:
Guidance Documents for Drug Master Files (DMFs) US, Canadian and European Regulatory Requirements
Role of DMFs in the regulatory approval process for drugs and biologics
Comparing the Types of Drug Master Files
Preparation of United States Drug Master File (US-DMF)
Preparation of European Drug Master File
Compiling necessary document for DMF Submission
Regulatory reviews of DMFs
Strategies for Communications with FDA and other regulatory agencies
EU and US efforts to harmonize DMF systems
Steps of DMF preparation
Essential Information for a Drug Master File
Key Documents associated with DMF
Customizing DMFs for particular products and businesses
Binder Specifications and Cover Samples
Annual Updates and Amendments
Techniques for tailoring DMFs to CTD format
Assessing supplier Type III DMF’s

Current Issues with APIs and Type II DMFs
Successful Preparation of Type III DMFs
Course Description

Drug Master File (DMF) is a master document containing complete information on a API. It is known as US-Drug Master File (US-DMF) and European Drug Master File (EDMF) or Active Substance Master File (ASMF) in United States and Europe and respectively.

It is a submission to FDA covering factual and complete information on its chemistry, stability, purity, impurity profile, packaging and cGMP status of any API. The Main Objective of DMF is to meet regulatory requirements and for Market Authorization (MA).

Manufacturers of pharmaceuticals, pharmaceutical components, and pharmaceutical packaging are constantly under to ensure that their Drug Master Files (DMFs) are in order. This pressure derives from the drug applicants, who are experiencing mounting frustration and mounting costs as their drug applications are held up in review before the Food and Drug Administration (FDA) and European agencies. Although the submission of a DMF is required by neither law, nor regulation. As voluntary filings, there are only minimal regulations governing the submission of DMFs. Instead, FDA has issued a series of guidance documents, all of which must be considered in filing and maintaining a successful DMF. Guideline for Drug Master Files (1989 & 1994); Container Closure Systems for Packaging Human and Biologics (1999); Changes to an Approved NDA or ANDA (1999); Analytical Procedures and Methods Validation (2000); and Changes to an Approved NDA or ANDA, Questions and Answers (2001).

This comprehensive 2-day training provides attendees with an understanding of the role DMFs play in the FDA's regulatory and European approval process. The course will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel.


Holiday Inn
Boston-Somerville 30 Washington St.
United States