Regulatory Transformation: Managing Change in a Complex World

If there is one thing that is constant in today’s regulatory world, it is change.

Recently, however, we are seeing an acceleration in the pace of change, both within life sciences organizations and regulatory bodies. In turn, there is a need to reframe RIM requirements to improve process effectiveness and operational efficiency. Many in the industry are now looking at a complete transformation as the only way forward.

Regulatory transformation is a journey. It starts by determining your regulatory solution strategy and defining your target operating model. Engaging with your technology vendors in innovative ways is the next step, followed by leveraging proven implementation approaches, before reflecting on the results and analyzing the benefits.

This journey is not the road less taken. On the contrary, it is one that has been road tested by many European life sciences organizations – with proven results. At our recent European R&D Forum in Copenhagen, we heard fascinating customer presentations from GE Healthcare Life Sciences, MSD Animal Health, Kinapse, and Covance as they discussed aspects of their regulatory transformation.

For example, by using a conference room pilot to proactively work with a vendor during a selection process, GE delivered a high quality assessment of how the technology would meet their transformation needs based on realistic scenarios. On the change management side, both MSD Animal Health and Covance discussions included the importance of engaging with stakeholders during implementation, as well as the need to focus attention on the right people for the right tasks. GE also noted the importance of measuring benefits, using innovative methods such as workflow tracking metrics to identify and report on process improvements.

All too often in the past, regulatory systems were heavily customized for current processes. However, as Kinapse reported in their presentation, we are now seeing a dramatic shift in the industry to leverage solutions such as Veeva Vault RIM to deliver best practice capabilities and configurations. Why? Because these kinds of solutions allow organizations to focus on the science and development of compliant content, rather than having to continuously maintain custom configurations that over time may not suit changing business requirements.

At the same time, compliance to health authority standards must always be at the forefront of any regulatory strategy. We have seen many examples recently, with the introduction of eCTD, xEVMPD, and other new standards. With a move to data-oriented standards such as IDMP, organizations need to have a handle on their data sources and implement good data governance to ensure data quality.

While at the outset at least, IDMP may have been seen to be just another regulatory standard, it now seems to be a key driver in regulatory transformation. All presenters observed that IDMP necessitates RIM solutions that can support evolving data requirements, otherwise life sciences organizations will once again be left with inflexible, heavily customized environments. At the same time, IDMP is impacting multiple organizational functions, so companies are recognizing that their RIM solution must provide a holistic view of regulatory processes and their interaction with other clinical and product supply activities.

Agility and the ability to adapt to change are necessary to stay competitive. This of course requires good stakeholder management to stay aligned with changing requirements. And it also requires flexibility and adaptability from technology solution providers to keep current – and stay one step ahead of change.

Change is inevitable. But being ready for change is a choice.

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