Regulatory Information Management (RIM) has been a core part of Regulatory Operations since the early 1990s. Great advances were made in the ’90s and early 2000s in content management, publishing and registration management, revolutionising how global submissions were planned, executed and tracked. But as Regulatory Operating models have evolved to embrace global working and the use of strategic delivery partners, and the focus on throughput, KPIs, metrics and efficiency has intensified, the traditional RIM systems have struggled to cope. The single biggest challenge in RIM today is the lack of an end-to-end process view of Regulatory. The traditional “system of record” view of RIM is largely missing the opportunities for process optimization and user experience improvement offered by digital and automation technology.
In the last couple of decades, regulatory technology has facilitated a huge rise in the number of registered products globally, but with this success comes the burden of maintaining these global registrations throughout their lifecycle. It is estimated that regulatory affairs departments spend approximately 70 percent of their resources on lifecycle management, driving large regulatory operating model changes in the last decade to lower costs and improve efficiency. Users of RIM suites are now dispersed globally and demand a user experience comparable with their personal consumer experiences. Complicated, unwieldy, confusing and slow systems that operate in silos and lack integration are no longer acceptable. Entering the same data in multiple systems in slightly different ways using non-standardized dictionaries and pick lists are potentially making data quality in RIM systems a significant global compliance issue.
In this webinar, the featured speakers will explore the current state of regulatory technology and how it is not fit for the challenges of regulatory lifecycle management and new regulatory operating models. As new integrated systems of record suites emerge, participants will learn about the need for a far-reaching, re-definition of “RIM” and how this new RIM paradigm needs to embrace user experience, master data, digital and automation technologies, and be focused on processes rather than capabilities. The speakers will also use real-life examples of a RIM transformation journey.
John Cogan, Head of Innovation & CTO, Kinapse, A Syneos Health company
John Cogan has 30 years of experience in the biopharma industry. He has held global leadership positions in R&D IT, IT Shared Services and Chief Technology Officer roles and been responsible for the delivery of major technology-enabled organizational transformations in regulatory, pharmacovigilance, clinical, medical affairs, IT and global business services. John is a recognized industry expert in regulatory information management and the opportunities to redefine RIM using digital technologies. He holds a BSc in Chemistry and an MBA from Warwick Business School.Message Presenter
David Berglund, Global Head Regulatory Operations, AstraZeneca
David Berglund is Global Head of Regulatory Operations at AstraZeneca MedImmune. Leading a global team focusing on document and submission publishing, lifecycle management of registrations, submissions and dossiers. Also leading the strategy and governance of the global RIM platform. David has been at AstraZenca for over 20 years and held several positions within Global Regulatory Affairs. He led the implementation of a consolidated RIM platform, headed the Regulatory Systems Management group and leads the re-imaging of the regulatory function using new levers such as automation, robotics and AI. David is based in Gaithersburg USA, but previously worked out of the UK and Sweden. David has a Bachelor’s Degree in Computer Science from Uppsala University Sweden.Message Presenter
Who Should Attend?
Senior professionals from biopharmaceutical companies and software providers involved in:
- Regulatory Affairs
- Regulatory Operations
- R&D IT
What You Will Learn
Participants will learn about:
- Historical overview and current trends of Regulatory Information Management (RIM)
- Emerging regulatory operating models
- Application of digital and automation technology to improve process optimization and user experience
- Redefining RIM
- An example of a RIM transformation journey
Kinapse, a Syneos Health company, is a leading advisory and operational solutions provider to the global life sciences industry. The company delivers its services across the full clinical and commercialization continuum and across global markets, collaborating with its biopharmaceutical customers to improve patients’ lives. Through a unique Advise – Build – Operate model, Kinapse delivers quantifiable business benefits and operational success. Headquartered in the UK, Kinapse has over 600 staff located in Europe, India and the U.S.