All Regulatory operations articles
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JournalOrganising high quality research and development data for success
Regulatory functions have long discussed the quality of the data in regulatory information management (RIM) systems, and various data entry models have waxed and waned over the years. According to current research, there is no correlation between the data entry model and the quality of the data in RIM systems. However, this article argues that managing data in research and development (R&D) silos is the key reason for variable data quality across the R&D data value chain, and that a change in how R&D operations functions are organised could be the secret to success.
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FocusThe changing role of regulatory operations
The regulatory profession has always attracted diverse individuals with a wide range of professional experiences. Top talent has migrated from preclinical labs, clinical operations, quality, and a range of functions to pursue a career in regulatory operations. The role of the regulatory operations professional has and continues to evolve as the requirements for the position have changed drastically. These professionals have witnessed a substantial change in the responsibilities associated with their role. These changes are directly related to those in global submission requirements and associated standards, emerging technologies, and shift ing resourcing models, among other factors.