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Solutions Showcase
Regulatory, Quality and Good Manufacturing Practices
Emerging Trends
Christopher Knerr
Chief Executive Officer
Mareana
The increasing scope, complexity, and integration needs of Global Regulatory requirements are placing new demands on regulatory leaders and organizations. Regulatory data, processes and systems are straining to evolve to meet these demands. Yet the Digital Transformation occurring in other areas has been relatively slow to take hold in regulatory. Companies that are able to initiate and advance regulatory data digital strategies will enjoy significant advantages not only in compliance, but also in efficiency and growth.
Business partners don't always understand the importance of the Regulatory function in driving growth for medical device firms: it's not just about compliance, it's also about enabling growth, quality and efficiency. Regulatory leaders understand that a strategic approach can yield both compliance and reduced time-to-market, quality improvements in post-commercial market surveillance and cost efficiency for the Regulatory function. Yet the fragmented nature of regulatory data and systems does not lend itself to driving these outcomes.
In this session we will discuss how to create, articulate, 'market' to senior leadership, and execute a Regulatory Data Digital Strategy that will unlock the power of full life-cycle, end-to-end data to meet emerging Regulatory market needs and enable organizations to be more strategic and high performing.
