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The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
A surge of change is underway in regulatory information management (RIM) as life-sciences companies re-evaluate their global operating capabilities. A report (1) by Gens and Associates shows that many organizations are embarking on significant transformation initiatives. Mounting pressure to operate more efficiently worldwide is driving companies to harmonize processes, improve data quality, and adopt shared global systems. For many, the spark of this movement is the Identification of Medicinal Products (IDMP) standard that requires regulatory teams to collate data from multiple sources and functions.
The accelerating pace for change
Industry analyst Steve Gens has been following RIM trends for more than a decade and has captured significant changes in a Gens and Associates report (1)
Pursuing World Class Regulatory Information Management (RIM); Strategy, Measures, and Priorities. A dramatic 86% are embarking on transformational change in one or more of the 17 regulatory capabilities tracked. According to the survey, 41% of large- and mid-sized companies plan to change their submissions content management systems within the next two years; 65% are changing their submission planning systems, and 73% are changing systems for managing health authority interactions.
Regulatory transformation initiatives are also bigger and broader than they used to be. Gens noted in the report that historically, companies would incrementally upgrade their regulatory capabilities with individual change initiatives. Today, however, regulatory change is treated as an end-to-end programme involving personnel from clinical, quality, and manufacturing divisions. Companies are reinforcing their new RIM strategy with organizational changes; for example, 45% of companies report implementing end-to-end process ownership and governance roles.
Generally, companies are pursuing four key goals:
A case study of regulatory transformation
Improving RIM efficiency and meeting IDMP standards share many of the same requirements: quality data, global alignment, and collaboration not just between departments but also with outsourced partners. The opportunity to innovate and achieve these goals is greater today than it has been in the past decade.
For example, by modernizing their RIM capabilities, UCB, a multinational biopharmaceutical company, has improved the efficiency and agility of the business and translated data quality into patient value. To begin, UCB formed a cross-functional team and outlined six core objectives. Within each, UCB focused narrowly on what was business-critical and would provide real patient value, recognizing that with a strong foundation in place, it would be able to scale up and address additional IDMP data points as needed. UCB’s six core objectives for RIM transformation include:
Companies may have once balked at the effort involved in standardizing systems, processes, and data globally. It is, however, increasingly clear that the gains in operating efficiency and regulatory effectiveness will generate a positive return and have motivated many to embark on their own transformation initiatives.
John Lawrie is vice-president of product strategy for the Veeva Vault RIM suite of applications.
Pharmaceutical Technology Europe
Vol. 29, No. 5
Citation: When referring to this article, please cite it as J. Lawrie, “Transforming Regulatory Data Management,” Pharmaceutical Technology Europe 29 (5) 2017.