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Fusion 2022 Explores the Integration of Safety, Regulatory & Quality Operations
Don Soong, Senior Director and General Manager, Quality Solutions, IQVIA
Feb 03, 2023

IQVIA recently hosted a customer conference, Fusion 2022, in Clearwater Beach, Florida. Fusion guests had the opportunity to learn how ongoing trends in the life science industry are driving new and innovative strategies across safety, regulatory and quality (SRQ) operations, as well as to interact with and explore game-changing technologies that IQVIA is using to meet the unique needs of safety, regulatory and quality professionals today.

Fusion 2022 also provided a forum for IQVIA to connect with customers and attendees through collaborative discussions on the challenges of today, and key trends that will impact the life science industry of tomorrow.

Current Approaches to SRQ Operations & Why They Need to Work Together

At Fusion 2022, IQVIA polled the life science attendees from around the world and found that only 20% currently leverage integrated safety, regulatory and quality operations. The other 80% are still performing SRQ operations in silos across the enterprise.

It’s becoming critical that SRQ teams work together due to the volume of data available, and the speed of regulatory change. Also, with the increasing demand in healthcare, there is the added scrutiny on the life science industry to gain efficiency.

Safety, regulatory and quality teams need to approach their operations in more holistic ways. The industry as a whole should be moving toward a future where data and common content serves as a foundational cornerstone for all SRQ activities. The data foundation serves as a common unifying asset between SRQ teams. So, activities can be strategized and executed based on harmonized real-time data-driven insights rather than delayed insights caused by information sharing bottlenecks.

How SRQ Teams Need to Work Together

When you look at a solution stack, you have three core systems: regulatory information database, a regulatory information management system (RIM), and a quality management system (QMS). When you combine those three systems, you have much better knowledge of and control for regulatory updates, as well as increased and enhanced change management across Quality and Regulatory teams.

Life science companies seeking to optimize processes across safety, regulatory and quality functions must also consider the impact of integration from an operational perspective. Each of these groups have their own unique processes, but they share processes as well. It’s those shared processes that need to be harmonized. As long as teams can identify those common touch points across the enterprise, their customers will benefit from increased efficiency around processes and people.

Each function typically possesses its own view and use of data. To share that data for global reporting, it needs to be accessible by each stakeholder across SRQ teams in a consistent manner. Today, sharing information across teams can be a clunky process. However, as you integrate the systems, harmonize data and leverage automation, that sharing of information and collaboration across teams becomes embedded in workflows. This ultimately leads to a more cohesive and unified strategy across SRQ activities.

How IQVIA Is Helping to Shape the Future of SRQ

One key goal for IQVIA in 2023 is to help customers, through strategy discussions and evolving IT strategy, bring SRQ operations and teams closer together. Through advisory boards, IQVIA is working with customers to optimize and validate strategies that integrate SRQ IT systems, processes and the people that drive success in those divisions.

Safety, regulatory and quality teams have faced numerous challenges in recent years – many of which were completely new and unprecedented, such as a global pandemic, regulatory requirements for digital data analysis, and more. While each team grabbles with unique obstacles, the data and systems they use can be harmonized and integrated to overcome shared challenges. Life science organizations that successfully approach the integration of SRQ functions and systems in a holistic way will undoubtedly be better prepared for the next wave of unprecedented challenges.

For more information on Fusion, visit the Fusion Event page. For additional questions, or to inquire about future Fusion events, please contact fusionevent@iqvia.com.

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