Pharmaceutical companies intending to market products in the EU must follow one of three distinct processes in order to obtain the required marketing authorizations - Centralized Procedure, Decentralized Procedure or Mutual Recognition Procedure. Of these, the DCP route, adopted to seek approvals where none currently exists, can be a challenging and complex process.
The AIPS Seminar is designed to assist in DCP Deficiency handling vis-a-vis multiple European Authorities. After providing an overview of the European Filing procedures, the seminar will focus on DCP Filing deficiencies,and study issues relating to their impact on the DCP review, the current trend of deficiencies, ways to address these deficiencies, the turn around time for addressing deficiencies etc.
The seminar is recommended for professionals in Process Teams, Analytical Teams, Purchase (API as well as KSM - Alternate sourcing and their impact on API resulting in variations at the formulators end vis-a-vis latest variation guidance which impacts cost of filing variations and launch dates], RA, Marketing, Quality and Production Planning Teams. Project Management officials, etc.
Venue: AIPS, Mumbai
Date: Saturday, May 8, 2010
For more details : info@aips.ac.inMay 2010
