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Drug Master Files (DMFs)
23-24 Feb 2010
Jersey City, NJ, United States
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Drug Master Files (DMFs)
Description
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
Interactive Discussion Sessions
Current Issues with APIs and Type II DMFs
Successful Preparation of Type III DMFs
Past Events
Drug Master Files (DMFs) - 23-24 Feb 2010, Jersey City, New Jersey, United States
(2340)
Important
Please, check "Drug Master Files (DMFs)" official website for possible changes, before making any traveling arrangements
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Health & Medicine:
Pharma
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