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Regulatory Programme Research: Scorecards
The objective of this programme is to achieve an internationally accepted balanced electronic Scorecard for monitoring the quality of regulatory submissions and their review.
Whilst the speed of review has a major influence on patient access to medicines, it is also important to recognise the sponsor’s role in the submission of a high-quality dossier and the regulatory agency’s responsibility to conduct a quality review. With this goal in mind, CIRS has developed and tested a Scorecard for measuring the quality of the regulatory submission and the review process.
CIRS conducted a retrospective pilot study involving three agencies and seven companies, with reported analysis on 42 Scorecards. Additionally, a CIRS database enables a profile to be constructed for each agency and company, which when analysed, identifies the areas in which organisations exceed standards or need improvement.
Although the Scorecards have been found to be of value by both companies and agencies from their inception, both agencies and companies have evolved the quality of their process and dossiers such that the time was right to revaluate the original Scorecard. An interactive Forum was held in 2012 to facilitate the development of two new balanced Scorecards and a detailed analysis of the Forum that includes a weighting of the Scorecard components based on the participant ratings, along with the final, balanced version of the Scorecards will be available in 2013.