AIPS will organise a three-day workshop on Drug Registration (Regulatory) Dossier Compilation to offer a practical insight into entire process for introducing a high investment drug into the commercial environment which is a challenging process. The event is scheduled to start on January 9, 2009 at AIPS, Goregaon (W), Mumbai.
Identification of the various sources of required information, collation of data collected, preparation of the dossier such that there is regulatory compliance, the registration procedure itself, the concept of a quality dossier, etc will be dealt with, and the focus will be to provide an understanding of the how and why of the entire compilation procedure. A practical and interactive approach will be adopted to maximize learning.
J B Chemicals and Pharmaceuticals Global Regulatory Management, president Dr Milind Joshi, Watson Pharma Corporate Regulatory Affairs head Babu Suri, Usha Kamath and Santosh Savarkar from Glenmark Pharma are the faculty for the occasion.