Pharma companies have been focused on integrating systems containing regulatory data, to automate data flows and enhance compliance. Now attention is shifting to how best to reveal interdependencies between data, documents and processes to drive efficiency and further automation. Romuald Braun, VP of Strategy for Life Sciences at Amplexor, offers some guidance to pharma businesses looking to optimise their regulatory information management (RIM) automation.

Keeping on top of regulatory requirements in life sciences is a full-time occupation, as the landscape is in a constant state of flux. The new demands each year are considerable, and 2021 will be no exception. It was already set to be a big year for new compliance deadlines, and now the continuing COVID-19 pandemic is driving new urgency around streamlining and accelerating processes and shoring up data quality.

In the EU, IDMP data-based marketing authorisation submissions are compulsory as of January 2021 for centralised procedures, and the new EU Medical Devices Regulation will fully apply in EU Member States from late May. Brexit is having an impact on the supply of medicines and medical devices in and out of the UK. The Eurasian Economic Union is working towards unified quality control of medicines. The US, Canada and China are continuing to make their own strides towards standardised electronic submissions and data exchange, as well as improved product traceability, meanwhile, as part of a global effort to ensure safer and more timely access to all kinds of medical treatments.

Keeping the regulators close
All of these evolving requirements put the onus on life sciences companies to stay close to the regulators, and to maintain sufficiently agile systems and processes to absorb each set of changes as they come along. In the best-case scenarios, organisations will be able to calculate the impact of emerging new requirements ahead of time and automate the cascading changes that are required.

Although life sciences companies have set an ambition to be smarter and more data-driven in their regulatory information management, with a sharp focus on integrating diverse data systems so that information can flow and be exchanged between them, too often these initiatives stop short of delivering tangible benefits because they don’t provide for process automation.

RIM integration creates the channels for data to flow between systems, but there are no rules for automating what happens to that data – how it is processed, the conclusions and the next actions that it triggers.

The true pathway to improved efficiency, accuracy and accelerated speed to market comes from the ability to understand the interdependencies between data, documents and processes, and to drive new process automation based on the latest regulatory intelligence. That might be to streamline and adapt the preparation of documents for marketing authorisation purposes, with the appropriate information for each market; to simplify and expedite variation management; or transform change management (impact assessment, then execution).

Regulatory intelligence-driven process automation would also make it possible to track status information more intuitively across all global activity, with the ability to drill down into the local picture in each market. Additionally, it could create the potential for automated alerts when new action needs to be taken, keeping Regulatory teams ahead of next requirements.

Companies have made some progress towards impact assessment and streamlined change management in areas such as packaging and labelling, so that if there is a change to a substance or to manufacturing, these can be quickly and reliably reflected across all relevant regulatory documentation and patient-facing information. But they could go further still.

The obvious next step to deliver additional benefits from integrated RIM is to apply it to changes to regulatory requirements globally – so that each incoming update is swiftly translated into practical implications and actions which can be automated to a significant degree.

Given that each country will often have its own specific interpretation of regional requirements, intelligence-driven regulatory information management (RIM) systems must be able to cope with substantial granularity.

Granular RIM
Particularly at a drug development/CMC level, the specific legal and government requirements can vary considerably – for instance in terms of corporate liability linked to adverse events and what needs to be disclosed in marketing authorisation documents.

Up to now, software vendors or life sciences companies themselves will have collated much of this regulatory intelligence, reflecting it in a database structure or series of document templates to serve the current market requirements globally, from eCTD and XEVMPD to SPL and UDI. Yet this mapped-out intelligence hasn’t necessarily translated into accelerated processes or failsafe submissions.

The challenge is to use this in-depth regulatory knowledge to drive new process efficiency. Instead of Regulatory personnel having to proactively search for the current requirements for Uganda, for instance, an intelligence-driven system would ideally expose that information and automate the process of creating compliant documentation.

Automation potential
This capability has existed to some extent for up to 15 years, but the scope for transforming processes is exponentially greater now. Today, there is an opportunity to extend and standardise this automation potential on a much broader scale.

Companies have long realised that the key to doing more with data, and saving on process repetition, is to integrate systems more tightly so that information does not have to be recreated numerous times. Adding a new system for each new requirement is costly, too, so the favoured approach now is to adopt information standards and web services to exchange data.

This is all essential preparation, but this strategy in itself does not result in a step change in process efficiency. It opens up the data highway, but does not provide the automation rules which will be necessary to manage the master data and its onward use without the traditional manual burden, for example when changes are introduced which will need to be reflected in multiple end use cases.
While it is highly desirable to establish a high-quality master data set, and have ready access to a pool of regulatory intelligence to inform document preparation, the key to process transformation is a configurable automation engine.

Pharma businesses can add this on top of existing integrated RIM systems, to process data and deliver it to where it is needed – to drive alerts, or to ensure that the correct information flows into place for each particular purpose.

One of the benefits of layering the automation engine on top of existing systems, rather than building the capability into the integrated RIM capability itself, is that this allows for company-specific rules without any configuration becoming a huge and costly bespoke development and maintenance burden. There is still substantial scope to synchronise the automation layer with other systems so that these can track the progress of automated tasks, and so on.

Accelerating processes, reducing error
Moving beyond RIM data integration towards intelligence-driven process automation carries huge potential to simplify the lives of data workers while accelerating processes and reducing the scope for human error.

Applications could include managing the different regulatory specifications for what to include on labelling in each region, with the potential to streamline variation planning and delivery; optimising local and global planning and change management/impact forecasting; and automated maintenance of foundation/master data and the cascading of changes to affected documents.
In the case of changes to a product master data item, the indication of a potential change could automatically trigger notifications of what the impact would be, before the decision is taken to action the change and set in motion knock-on actions in linked business processes.

To get the maximum return on their RIM investment, pharma organisations must prepare to take the next step. Adding intelligence to process automation is the secret sauce that will accelerate operations by reducing the time and risk associated with marketing authorisations.