Regulatory affairs departments are accustomed – and even open — to change and adapting their technology and processes in response to compliance and business pressures. Typically, regulatory affairs leaders respond to such drivers as “how do we improve efficiency?,” “how do we speed the process to improve time to market?,” and “what do we need to do to get the right information from affiliates on time?”
But in an age of heightened collaboration combined with a push for greater harmonization around the way products are developed, manufactured, delivered, marketed, and reimbursed, regulatory affairs is having to consider wider business drivers.
That’s not to say that efficiency, time to approval, and affiliate management aren’t important, but rather that these are operational issues, whereas business drivers extend far beyond into strategic business matters.
Regulatory Affairs: Prepare for Disruption
It’s clear now that for the regulatory affairs industry to transform and respond to disruptive innovation, it must move away from point solutions and start to respond – from a process and technology point of view – to the larger drivers the entire company is facing. Those drivers have potentially huge ramifications for industry, including pricing pressures, audit expectations, managing the supply chain, and the transfer of documentation across the enterprise and beyond.
Equally, those drivers extend into new ways of doing business and interacting: the Internet of Things, social media, artificial intelligence, and blockchain technologies.
While regulatory affairs may well question how many of these issues affect them, the reality is in today’s more connected environment they soon will, and progressive organizations should prepare now by building the 2020 regulatory information management (RIM) technology landscape to successfully manage the transformation. Quite simply, regulatory – and indeed any department – can’t go it alone, they need to work collaboratively to tackle the disruption that can potentially advance innovation.
Over the next few weeks we’ll explore the themes of cross-functional business drivers and next-generation digital trends, how these are impacting regulatory affairs, and technology responses affecting the regulatory compliance management system that are needed to achieve future success.
Join Pratyusha Pallavi, Product Manager – Regulatory, at the eRegulatory Summit, April 25-27 in Madrid, where she’ll be presenting on the topic of Regulatory 2020: Technology-Fueled Business Transformation, and where ArisGlobal will be also exhibiting.
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