The Academy of Intellectual Property Studies (AIPS), is organizing a workshop on Drug Master Files - Compilation and Compliance' at Goregaon (West), Mumbai, on May 22 & 23, 2009.
A Drug Master File (DMF) is a confidential, proprietary asset containing complete information on an API. It is a submission to the FDA, and plays a crucial role when applying for regulatory approvals and market authorization. Acting as a master document, the DMF is important in maintaining current supplier agreements as well as in developing new business relationships and their preparation is, therefore, an important function in pharmaceutical organizations.
This workshop aims to train executives on how to prepare reliable and efficient DMFs that are compliant with official guidelines and requirements. An interactive teaching method will be used, and participants will gain an understanding of the role of the DMF in the regulatory approval process, how to compile a DMF in different jurisdictions including what to include / not include, maintenance of the DMF, strategy to avoid unfavourable reviews, etc. Executives from the RA, R&D, Quality Assurance and Control, Manufacturing and Validation will be benefited by participating is useful workshop.