Workshop on Drug Master Files - Compilation & Compliance
May 22 and 23, 2009 .
Venue: AIPS, Goregaon (West), Mumbai
A Drug Master File (DMF) is a confidential, proprietary asset containing complete information on an API, 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 find participation especially useful.
Workshop on TRADEMARKS, GEOGRAPHICAL INDICATIONS
Apart from the Fundamentals, sessions will cover areas such as Practice in India, Trademark Registration in India and internationally, opposition procedures, International Treaties, Role of Enforcement authorities, Trademark Search, Trademark Licensing and Management, Brand Valuation, GI fundamentals and protection, Geographical Indication Act 1999 etc.
