Veeva : Regulatory Transformation Insights from the Veeva R&D and Quality Summit, Europe

After meeting virtually for the last two years, we were thrilled to welcome more than 150 people to the regulatory zone at the 2022 Veeva R&D and Quality Summit in Zurich. It was a gratifying and long-awaited opportunity to connect and learn from a global community that includes 300+ biopharma companies and over 25,000 daily users of Veeva Vault RIM.

The theme of the day was delivering value in regulatory transformation. Several regulatory organizations shared their transformation journeys, including the benefits and best practices they discovered along the way. In addition, Veeva's product leadership outlined our strategy for helping regulatory organizations increase productivity via automation while satisfying new data submission standards.

The path to global regulatory transformation

Lorna Bruce, head of regulatory systems and processes at GSK, described how the global pharma leader adopted agile methodologies to accelerate change, increase standardization, reduce process complexity, and eliminate low-value tasks. After eight iterative releases over 3.5 years, GSK achieved a single health authority submission process for 10,000 end users. "With the introduction of Vault RIM, we now have the capability to more quickly and effectively bring new products to market whilst better managing our product lifecycle," said Bruce.

Streamlining the regulatory process

Helen Donnelly, head of RA systems and analytics at Mundipharma, explained how they used Vault RIM to unify regulatory information and processes across 120 operating countries and two major product portfolios. With Vault RIM as their single source of truth, the fast-growing company improved data compliance, data visibility, and organizational decision-making. In addition, the regulatory team now works more efficiently with a 35% reduction in manual hand-offs. "By changing our processes and implementing Vault RIM, we've changed the way all of Regulatory operates," Donnelly said.

Using IDMP to advance regulatory transformation

Dr. Andrea Herrmann from Merck, Emma Luke from AstraZeneca, and Olivia Maurel from Sobi joined a panel on IDMP readiness. A key takeaway from the discussion is that IDMP preparation is an excellent opportunity to improve data management practices. The panelists described the new roles, processes, and technologies they've adopted to increase data governance and quality. These include setting up a regulatory data office, establishing data rules and standards, educating people about the cost of poor data, and limiting most data entry to a dedicated team of submissions managers.

Innovating for-and with-customers

Eldor Curovic, VP product management, shared Veeva's vision for helping regulatory teams in three key areas: productivity, automation, and compliance. He also previewed upcoming capabilities of Vault RIM, including enhancements to label management, content plans, the submissions wizard, and the submissions archive viewer plus new support for data submissions. Customer initiatives are an important input to the Vault RIM roadmap, so thank you for helping us chart a course for regulatory transformation.

It was fantastic to see our customers in person, and we can't wait to reconnect next year. Save the date for our upcoming R&D and Quality Summit in Madrid from June 6 - 8, 2023. In the meantime, you can watch sessions from the Regulatory zone of the 2022 Summit on demand.