EVENT DETAILS
Drug Master Files (DMFs)
Strategy for Meeting Your Regulatory and Processing Responsibilities
February 23-24, 2010 - Jersey City, USA
A Two-day comprehensive and interactive course 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 Canadian & 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
- DMF Preparation and Requirements
- 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
- Current Issues with APIs and Type II DMFs
- Assessing supplier Type III DMF’s
- Successful Preparation of Type III DMFs
Link: http://www.ipacanada.com/viewcourse.php?id=dmf0210nj-1 |
