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