Top Pharma Companies Discuss Regulatory Transformation at Veeva R&D and Quality Summit
Although we missed connecting in person, we were pleased to welcome more than 500 people to the regulatory track of the 2020 Veeva R&D and Quality Summit Online. Over the course of two days, Summit attendees participated in small group discussions, watched live demos, and joined sessions led by 12 different Veeva Vault RIM customers.
The Regulatory track kicked off with a fireside chat featuring two heads of global regulatory operations. Dominique Lagrave of Amgen and Gina Schmidt of Sanofi—both Veeva Hero award winners—provided practical advice for organizations undertaking a regulatory business transformation.
Lagrave described Amgen’s four-year, multi-phase journey to bring together regulatory data and documents in a single source of truth. Their Vault RIM solution now supports nearly 10,000 users with streamlined, end-to-end regulatory processes for submission planning through archiving. Lagrave called change management one of the project’s biggest challenges and encouraged attendees to engage the business early to ease the transition to new ways of working.
Schmidt shared Sanofi’s experience replacing 50-plus legacy systems with a global Vault RIM solution for all products, markets, and functional areas. She said a key objective of the transformation is to enable more data-driven decision making throughout the company. In a later session, Marianne Smith, Joe McLaughlin, and Donna Wolfington echoed that sentiment when they shared Sanofi’s strategies for driving a cultural shift that makes improving data quality everyone’s responsibility.
The regulatory track’s second fireside chat focused on the benefits of taking an agile approach to RIM implementation and business transformation. Veeva welcomed back Dr. Stephen Cook, regulatory processes and systems business lead at GSK, who credited an accelerated RIM rollout to agile system delivery. He also explained how an agile mindset helped his team realize opportunities for Vault RIM to transform the daily work of colleagues in clinical, non-clinical, CMC, and manufacturing.
Regina Freunscht, head of global regulatory operations at Merck KGaA, Darmstadt, Germany, said agile working methodologies reduced the time and resources required for their global Vault RIM implementation. Freunscht also stressed the value of agile thinking and processes in today’s rapidly changing regulatory environment. Merck KGaA’s transformation is ongoing, and teams continue to “create their own future.”
In addition to a full slate of customer-led sessions, Summit attendees also heard from Veeva’s product management experts in two roadmap sessions. Kate Wilber and Kelly Finlan-Dansbury explained how Vault Registrations is evolving to support new IDMP regulations. Later that day, Uri Reich, Cindy Ling, Rich Merrick, and Rolando Sa shared enhancements for Vault Submissions, Vault Submissions Publishing, and Vault Submissions Archive including a key initiative around Active Dossier.
To view these and other Summit sessions on demand through November 13, please register here.