Current regulatory reforms: CBER

Abstract

• 1. To achieve the strategic objective of managing the review process from discovery through to post-marketing surveillance, the Center for Biologies Evaluation and Research (CBER) has established a managed review process project. The aims of this project are to identify existing obstacles to managed review, to design new business processes and improve existing or eliminate redundant processes.

• 2. To this end, a number of core teams have been gathering and analysing information. The Center’s business processes have been mapped in great detail and first line recommendations are now being considered by the Managed Review Committee before a transition plan is developed and implemented.

• 3. A quality assurance unit was established in 1996 to monitor the managed review process and determine its effectiveness. This unit also serves the function of ombudsman for dispute resolution, ensuring fairness and consistent policy application.

• 4. The unit has primary responsibility for auditing the review process. Quality measurements of importance are identified and routine programme evaluations conducted. In addition, oversight meetings are held to scrutinise the reasoning behind ’clinical hold’ and ’refuse to file’ decisions. These meetings have proved useful, not only in reversing some of the decisions but also as a staff training exercise.