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IPEC Europe

Supporting the interests of pharmaceutical excipient developers, producers, distributors and users.

Objectives

 Objectives of the Quality & Regulatory Affairs Committee

 

The Quality and Regulatory Affairs Committee is in place to provide a forum for membership to enable discussion on relevant topics and to share best practices as they relate to various stakeholders in the pharmaceutical arena, ie makers, users and distributors of excipients.  As a committee we operate by:

 
  • Monitoring proposals by the regulatory agencies to amend legislation in our region
  • Providing consolidated feedback to those regulatory agencies
  • Monitoring trends within the pharmaceutical industry which potentially impact excipients, such as Quality by Design and the Paediatric Initiative
  • Developing and issuing position papers on relevant topics
  • Developing and promoting guidance documentation to assist both the members and outside interested parties
  • Working with other members of the IPEC organisation to acheive a global position on selected issues, such as cGMP

 

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