Regulatory Affairs Planning – Finding The Quality Data

The life sciences industry is awash with data from both internal and external sources – including data from clinical trials, data from disease and patient registries, regulatory data, data created by patients and healthcare professionals, commercial data. Companies need the information to make good decisions, especially when it comes to Regulatory Affairs planning for various process areas and functions within the organization. So, the real challenge lies in knowing what data is useful and what is simply “noise”- and finding the quality within the quantity.

Increasingly, life sciences companies recognize that regulatory intelligence solutions are a necessity, not simply a nice-to-have. But what is regulatory intelligence? There are three main areas that inform the field:

1. Surveillance or monitoring of requirements or regulatory changes in countries where products are marketed
2. Developing specific questions for strategic insights and use
3. Managing the engagement with the regulatory authorities

As the need for regulatory intelligence grows – both in need and in complexity – companies are starting to have dedicated RI functions. These companies recognize that having their regulatory people manage intelligence gathering as a side activity is no longer feasible. However, for many companies, RI remains reactive rather than proactive activity. For example, regulatory might uncover a non-compliance issue and carry out a root cause analysis to determine the cause and how best to address the problem.

Currently, most companies are not conducting impact analyses from a proactive point of view, which would help them to anticipate an issue or even make good commercial decisions ahead of the competition. All too often, knowledge remains siloed. What is needed rather is to turn that information into strategic corporate knowledge. This would require a change in internal processes, cross-functional communication from a regulatory intelligence perspective, and a dedicated knowledge management solution to determine the value of the insights gathered.

That’s where Celegence’s Simplified Regulatory Intelligence (SRI) platform makes the difference for regulatory intelligence functions.

For example, an internal team might carry out an impact assessment on a regulatory change in a specific market or filter for specific information to guide strategy when launching a product into a new market. Once carried out, the team would need a central place to store their analyses so that other functions can assess their own level of involvement for any required changes or actions. The regulatory intelligence team will also want to analyze multiple sources of data, including agency websites, conferences and forums, trade associations, analyst insights such as intelligence compiled by research groups, as well as other regulatory intelligence services.

Sifting through all this information, deciphering it, and organizing it into digestible components for the right people is complex and time consuming. The SRI platform has a defined data structure for storing regulatory intelligence which helps organizations stay ahead of mandatory requirements worldwide. For example, if there’s a change, the solution can specify which process area or part of the business is affected — such as the publishing and submission, manufacturing, or labelling – and what action is required. The relevant business units are then sent an impact assessment, so they are able to take quick action.

As the need for impactful and targeted regulatory intelligence becomes more and more pressing for the Life Sciences industry, it won’t be enough to simply gather data. The ability to filter and digest it will become a greater priority. And that’s the missing piece of the puzzle that our Simplified Regulatory Intelligence System fills for the industry.