Embracing Regulatory Transformation at Veeva’s 2019 R&D and Quality Summit, Europe
“A spaghetti bowl of systems”, that’s how Richard Eddershaw, head of regulatory systems and services at GSK Pharmaceuticals, described the company’s aging technology landscape to a packed room at the 2019 Veeva R&D and Quality Summit, Europe. In the autumn of 2018, GSK began replacing those legacy systems with a single, global, end-to-end regulatory platform and within six months, their first users were live with Veeva Vault RIM. Eddershaw explained how the company adopted an agile approach to release new functionality every few months, which has helped his team quickly demonstrate value to the R&D business.
Eddershaw’s presentation set the stage for a series of talented speakers in the regulatory track, including GE Healthcare, BMS, UCB, and Norgine. As the day progressed, conversations shifted from how to take that first step toward regulatory transformation, into implementation lessons learned, and ways to measure RIM success.
James Hendry, the head of global regulatory operations at GE Healthcare, shared his experience with the company’s rollout of Vault Registrations, Vault Submissions, and Vault Submissions Archive. He provided guidance in seven critical categories and highlighted some early usage numbers showing strong system adoption. Hendry also shared several comments from Vault RIM users including one that said, “overall it’s a breath of fresh air for regulatory records!”
In a shift from the typical presentation format, Lianne Wolf, the head of regulatory sciences Austria at BMS, sat down with Veeva’s Paul Attridge for a fireside chat. Wolf discussed how her regulatory team implemented Vault Registrations in three phases with the goal of having a “one stop shop” for all registration and submission planning information. She also emphasized how BMS incorporates user feedback and does periodical “pulse checks” to prioritize functional enhancements.
Later in the afternoon, Mark Morris, the director of regulatory knowledge at UCB, drilled into the company’s challenges with label management and demonstrated how Vault RIM improves visibility into workflow completion, cycle times, and content development across different regions. As a result, UCB saw measurable improvements in text control and completion, and is now able to provide targeted training and process support based on activities within the system.
To finish out the day, two speakers from Norgine, Jade Knight, partner services manager, and Segren Bernard, associate director of regulatory information management, described how they harmonize system processes and streamline reports with Vault RIM. They also shared how to maximize performance by establishing clear KPIs, benchmarks, and support tools, which enable teams to continuously adapt and improve.
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