Podcast

The Challenge of Change Management

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, we’re joined by Preeya Beczek, Regulatory Affairs and Compliance Expert, to dig into the real challenges behind change management, and what it actually takes to make it work in practice.


The Process Isn’t the Problem

Change management sits at the heart of product lifecycle maintenance, and here’s something Preeya and I both agreed on early: the end-to-end process itself is largely the same from company to company, because it’s grounded in the same regulations and guidance. Walk into five different organisations and you could play spot-the-difference on their work instructions without finding much.


So if the process isn’t the variable, what is? It’s what happens at the document and data level; where siloed information, spreadsheet workarounds, and unclear ownership start to creep in. As Preeya highlighted, challenges often come from infrequent users, language barriers, people wearing three or four hats in a single role. That’s where even a well-defined process starts to wobble.


I shared my own version of this. Working in a centralized RIM team, I used to get so frustrated when countries would send me spreadsheets instead of just entering data into the system. Then I went and worked for a local regulatory team and immediately understood. When a system isn’t easy to use, tracking things in a spreadsheet becomes the path of least resistance. The siloed information isn’t laziness; it’s a setup problem.


Where the Handoff Breaks Down

Preeya’s view is that most companies have the end-to-end flow about 80% right. What they consistently struggle with is the handoff. It’s that critical moment where regulatory needs to pass a change across to supply chain, packaging, or whoever is implementing it on the ground. Any delay there has a real cost, whether that’s compliance risk, a patient safety change that can’t be implemented, or a manufacturing improvement that’s stuck waiting on paperwork.


The fix starts with alignment: a shared, visible process that everyone actually understands, connected systems so data doesn’t have to travel by email, and leadership asking the right questions, like how many safety variations were missed last month, to create genuine accountability.


Where AI Can Make a Real Difference

This episode also got into AI and automation, and Preeya made a useful distinction between the two. Automation handles structured, repeatable tasks, narratives to a CSR, signals to a PSUR entry. AI is different: it gathers information from internal and external sources, analyses it, and gives you an output to review.


For change management specifically, some of the most practical use cases being explored right now include using AI to identify which SOPs need updating when a regulation changes, drafting those updates for human review, and analyzing health authority questions to surface how similar queries were answered before, so responses stay consistent across markets. Preeya also flagged label strategy as a strong candidate: instead of a regulatory lead manually reviewing public EPARs for comparable products, AI can tabulate and highlight the relevant information.


Preeya’s Three Top Tips

If you’re thinking about modernizing your change management approach, Preeya left us with three pieces of advice, not in any particular order:

  • Make it cross-functional from the start. Change management should never be seen as a purely regulatory activity. Safety, supply chain, clinical, logistics, packaging…everyone needs a seat at the table.
  • Education, education, education. Never assume someone in another function knows what you know in your domain. Bringing people along, explaining the why, is consistently underestimated.
  • Assess your local affiliate capability. Central teams often carry the full load for years without questioning whether local affiliates could take on more. They’re a gold mine of language, relationships with health authorities, and time-zone coverage. With the right support, they can take real pressure off the centre.

Preeya’s Top Resources:

If change management feels more complex than it should, this episode is a great place to step back and see where better alignment, across people, systems, and data, can make the real difference.


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