Globally, regulatory intelligence teams play a critical role in ensuring the safety, efficacy and quality of drugs. As such, regulatory professionals must function as a bridge with regulatory bodies to effectively drive ongoing compliance. Here, relevant and timely insights are critical.
Unfortunately, it’s no secret that amongst regulatory intelligence professionals, one of the most difficult tasks is identifying the right information. Typically small regulatory teams are becoming strained, and this problem is only worsening. After all, even once this critical information is in your hands, you then must be able to effectively analyze it and get this under the noses of key stakeholders.
For some, being able to do all of this in a timely manner feels impossible… but we’re here to show you it’s not. Here’s how some small changes to your regulatory workflow can keep you operating proactively in an ever-changing landscape.
Common pain points
There are a number of factors that contribute to the burden faced by regulatory professionals when searching for information. But what are the most common pain points when it comes to identifying relevant regulatory updates?
- Information overload: Every second, the amount of global data grows. In the life sciences regulatory space, a new guideline is now issued every 22 minutes. Of course, with increasing information comes an increased likelihood that a critical update will be missed, risking legal and financial ramifications. If regulatory teams do manage to keep track of this saturated and dynamic landscape, an enormous amount of resources are spent doing so, meaning workflows are extremely inefficient and intelligence lacks timeliness.
- Increasingly complex landscape: On top of an ever-growing datasphere, the regulatory landscape is becoming increasingly disparate – spanning innumerable databases, health authority websites, and even social media channels. When trying to monitor more niche regional bodies, this challenge only worsens. What’s more, recent changes such as Brexit and Swiss-exit are widening the gap between various global authorities, as former blanket policies develop regional discrepancies.
- Growing pressures and expectations: The role of the regulatory intelligence function is far more demanding than it used to be. Where regulatory teams were previously responsible for monitoring and communicating updates, they are now expected to play a key strategic role. Increasing expectations include performing due diligence on existing and emerging drugs to identify business opportunities, and collaborating with competitive intelligence teams to provide a 360-degree view of the landscape. And all this must be fulfilled at record speeds in order to enable faster Time To Market (TTM), as normalized during the coronavirus pandemic.
The value of timely, actionable regulatory intelligence
As a result of the growing demands of their role, regulatory teams occupy a unique position as both functional information gatherers and strategic information users. When gathering information, regulatory professionals value relevant intelligence sourced via efficient workflows; when utilizing information, they value strategically actionable intelligence.
So, why is achieving relevant, timely and actionable intelligence so critical? The reason is two-fold…
- In their function as information gatherers, regulatory teams must be confident that no data is missed – mitigating the legal, financial and reputational risks of non-compliance, and ensuring no business opportunities are overlooked.
- Meanwhile, in their function as information users, these teams must dedicate as much time as possible to interpreting regulatory insights – maximizing the data’s value. When their workflow efficiency is optimized, teams gain the capacity to devise, deploy and deliver a proactive global regulatory strategy, driving wider business success.
However, despite the undeniable value of timely, actionable insights, organizations often lack the time and technological resources to achieve them. How can regulatory professionals optimize the way in which they monitor, analyze and communicate relevant insights, to mitigate the risk of non-compliance and drive wider organizational success?
Assessing the current state of play
There are a number of ways in which regulatory professionals can optimize their regulatory workflows; so much so, it can sometimes feel hard to know where to start. First, you must assess the current state of play. According to Carol Stinson Becker, Senior Global Director of Regulatory Intelligence at AstraZeneca (in an interview with InfoDesk):
“You’ve got to understand what you really need to drive your organization forward, and then you have to do the hard work of investigating whether the technology that’s out there really matches up with what you want to do.”
So, what are the challenges and needs of your team? Here are some pointers to get you started…
1) Tackling information overload
The problem of information overload is growing, and it can no longer be tackled by human intervention alone. By leveraging purpose-built technology in the monitoring and gathering of data, teams can significantly optimize their surveillance of the regulatory landscape. This is an incredibly efficient way to gather relevant information, giving regulatory professionals the confidence that no updates have been missed.
2) Centralizing your data
Now you’ve tackled information overload, it’s time to take on data silos. The answer? Centralizing your internal and external regulatory data into a single, globally accessible source of truth.
3) Managing your insights
While gathering and collating your data is critical, you must ensure you manage this centralized information effectively. Consider the specific information needs of your team and the wider business, and ensure the way in which your insights are managed is in direct alignment with this. Organize intelligence into topics most relevant to your workflow: global regions, therapeutic areas, regulatory bodies, or trade associations. Housing your information in this way enables key stakeholders to search for the insights they need, when they need them, empowering data-driven decision-making.
4) Communicating insights effectively
So, your information has been collated, centralized and organized… But is it contextually meaningful? Consider what the key updates mean for your team, business strategy, and the wider competitive landscape. Summary sections can help with this, communicating the most critical takeaways in a succinct, digestible format.
5) Personalizing delivery
To deploy a truly effective intelligence solution, your end-users must be able to interact with information in a way that is right for them. This moves the conversation from one size fits all, to one size can be adapted by all – ensuring they have the right insights, in the right way, at the right time. Something as simple as a government hinting at a new policy or regulation can mean wildly different things (requiring entirely different insights) to different teams. It is therefore critical that your information delivery is capable of tailoring and refining the business-critical insights to each and every member of your user community.
Optimizing your regulatory workflow
Now you’ve identified your information challenges and needs, it’s time to address them.
Digital transformation holds the key. By embedding systematic intelligence procedures, strategies and technologies into the development and commercialization of all drugs, teams will be able to facilitate their growing workload and optimize their workflow.
We’ve given you the tools to communicate the value of a digital transformation to key decision-makers, so now it’s your turn. Go and get their buy-in.
Are you ready to maximize your strategic regulatory impact with efficient, timely, actionable intelligence? Click here to find out how to implement your digital transformation in 3 simple steps.