Wave 2 of ISPE’s quality metrics pilot is being designed to enhance the understanding of the relationships between the metrics that emerged into relief during Wave 1 and to provide further support for FDA in developing a more data-driven regulatory process.
To help enrich the data set and its value, ISPE is seeking to: ● increase the number of sites, technologies, company types and geographies that are involved in the Wave 2 effort ● collect data over a longer time to examine trending patterns, and ● evaluate the logistics of gathering product data at an application level.
The larger Wave 2 goal, ISPE is stressing, is to deepen the dialogue on how to achieve the 21st Century vision enunciated by CDER Director Janet Woodcock of a more flexible, efficient and transparent regulatory process and to move industry into a more prominent role in achieving it.
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