The Institute for Regulatory Science is currently involved in several activities related to quality as it applies to regulatory submissions and procedures, rather than the more conventional association with the quality assurance of the medicinal products themselves. Much of the Institute’s work in this area can be traced back to the Workshop on Building Quality into Regulatory Dossiers and the Review Process, held in December 2004 in Surrey, UK.
Recommendations from this Workshop related to monitoring and measuring the quality procedures adopted by companies and regulatory agencies and this briefing summarises the ways in which these have been followed up by the Institute and also provides highlights from the meeting.