The Academy Of Intellectual Property Studies (AIPS), Mumbai is holding a two-day workshop for drug regulatory professionals. The workshop will focus on Drug Master Files – Compilation & Compliance on November 13 and on November 14 it will concentrate on Drug Marketing Authorization Procedures in Europe.

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 will train executives on how to prepare reliable and efficient DMFs that are compliant with official guidelines and requirements. Participants will gain an understanding of 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

The European Union offers a very profitable market for pharmaceutical products - the EU market is, however, highly regulated, and the related regulatory requirements are both complex and dynamic.
day-2 of the workshop will focus on the EU compliant Application process required to secure marketing approval and access the market, and include discussion on topics like authority (HMA) responsibilities, different MA procedures and their scope, documentation required, post Authorization activities etc. Manufacturers and exporters in the pharma sector seeking to improve their export prospects to the EU will find the participation useful, as will professionals dealing in drug regulatory affairs.

For more details contact: gita@aips.ac.in or info@aips.ac.in