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Regulatory transformation: the time is now

Written by Siniša Belina on 21/06/16

Regulatory compliance has always been a double-edged sword for life sciences. It is an essential and central focus for investment because public safety, consumer confidence and sales depend on it. Yet this preoccupation with rules and risk can also be a barrier to innovation, because any deviation from the status quo increases the chance of non-compliance.

This is a problem for the pharma industry, because maintaining a clean record and keeping patients safe is not the only challenge it faces. Companies are also under growing pressure to be more responsive, more open and transparent, more adventurous and experimental, and more aligned to broader developments in the market (such as digital health initiatives). A conservative, risk-averse environment is not an ideal to promote and cultivate these traits.

The call for greater agility, openness and boldness means that Regulatory decision-makers need to look up from their immediate remits and play a more proactive and facilitating role in organisation-wide information delivery. Instead of focusing solely on becoming more efficient at responding to medical authority requests, Regulatory Affairs functions need to be looking for opportunities to share and recoup some of their investment - by extending the benefits of better information management to the rest of the business.

In this context, the recent announcement that pharma companies now have until 2018 to comply with the new global Identification of Medicinal Products (IDMP) information management standard is very good news. Originally, organisations were facing a deadline of this July to get their processes and systems in order. As that date got nearer, many companies were doing what they usually do when faced with a big change and a looming cut-off date: focusing solely on what they needed to do to keep the right side of the authorities. Any thought of additional business benefits had been put on the backburner.

The extra breathing space means companies have a chance to get back on track, and to resume conversations with the broader business about what a more structured approach to information management, across the various operational boundaries, could achieve and what this might look like.

While there is much buzz around ‘digital transformation’ in life sciences at the moment, it was regulatory transformation that dominated the agenda at Amplexor’s recent industry conference in Salzburg, and this is no coincidence. If entire pharma organisations are going to deliver the sweeping changes needed to enable collaboration, customer centricity and fresh business models, they first need to transform the agility and scope of their regulatory information management. Get this right, and companies can start to move more swiftly and confidently towards their newer, more ambitious goals – without fear of compromising regulatory vigilance.

In short, unless RA operations are progressive, what chance does the wider business have?

Think big

The step change needed is considerable, so it is a boon that companies now have a much longer run-up to IDMP. IDMP is not just about different and better ways of supplying required information to the Regulators. It is about a more robust and comprehensive way of managing the associated data, with ramifications - as well as numerous benefits - for many other business functions, from manufacturing to sales and marketing. It also supports greater collaboration and data exchange, not just internally between different departments and geographical locations, but also with supply chain partners, the broader medical profession, and with customers.

As long as companies rely on Excel spreadsheets to capture, store and distribute data, their opportunities to do more than tick boxes for Regulators is extremely limited. Without validation and proper controls, there is no certainty that the information as it exists in the local system is consistent with that which has been submitted to the authorities. And when information is being collated across multiple countries, with or without involvement from affiliates, there are further dimensions that affect consistency – even if the company has put in place procedures to try to maintain a level of control.

Standardisation helps overcome these inconsistencies, allowing regulatory departments to move towards a single version of the truth – an authoritative master data source which, irrespective of where this is located, is where all updates happen and is the sole feed into all other systems and outputs. Once everyone is using the same parameters and original data set, confidence in that data increases and it becomes easier to achieve cross-border transparency.

Although its primary concern is boosting patient safety, IDMP encourages this kind of discipline. In imposing a data-based standard, it isn’t concerned only with finished documents and submissions, but the content and context of those assets - so that all of it becomes searchable data, stored in a standard format that a range of systems can understand and use.

Once companies have that, they can call up information quickly, automate content redaction and perform numerous other actions on the data – efficiently, reliably, comprehensively and in a way that is highly traceable and auditable. Retrieving accurate, current data and collating reports then takes a fraction of the time it had taken traditionally, and painstaking manual processes of re-entering and triple-checking information are eliminated.

Intelligence for all

Regulatory departments haven’t been used to – nor have they especially needed - this kind of responsiveness until now. But as compliance criteria expand and become more complex, and as pharma organisations become more ambitious in their future commercial plans, that need is growing. Where once it was just pockets of the organisation - sales teams or manufacturing operations - that benefited from advanced information systems and had the latest data at their fingertips (via a mobile or tablet), that imperative is now fanning out across the enterprise.

Being able to deliver good-quality regulatory information quickly to support perpetually evolving and tightening compliance requirements is one thing (and something the revised IDMP deadline helps to make possible). The next consideration - and the bigger opportunity – is to make systems more interactive and capable of supporting more dynamic information management in other areas.

Another reason to take a broad, all-encompassing view of regulatory information management is that the specific requirements for IDMP implementation are still being agreed. Being able to comply with the detail still depends on the Regulators issuing final guidelines, and of course each region – the FDA versus the EMA, for example – is likely to have its own particular roll-out plan.

In the interim, leading companies are using the time to assess their existing data assets to establish where these currently reside and what may be missing. Unstructured data, tucked away within documents, needs to be extracted and tagged so that it can be called up in searches and exploited for other uses. The scenario companies need to work towards is one where everything – the detailed content of submissions, translations, and information about surrounding activities (correspondence with partners and affiliates, for example) - can be captured, managed and shared readily and in a user-friendly way. That means supporting data access (without any need to re-enter the information) within other operational and business systems – including ERP systems, labelling management systems, sales systems, and manufacturing systems.

By devising such a big and comprehensive data model in IDMP, the industry globally is promoting that wider perspective and wider use case. This is a data model that spans all of the departments of pharma organisations in one way or another, and all functions will need to feed it in an IDMP-compliant way, so the benefits should flow both ways.

Establishing a plan

Calculating the return on investment isn’t immediately straightforward as there are so many variables: the scale of the transformation will depend a lot on how systems look now. Just from leveraging RIM system content rather than using spreadsheets and manual processes to look up information should deliver administrative time savings of at least 30 per cent. And that’s before any of the broader business benefits.

Commonplace transactions such as selling on dossiers to other manufacturers or resellers are vastly simplified too. In place of scanning boxes worth of paperwork, dossiers can transferred electronically.

In a digital age, where old models are being challenged and disrupted, old ways of working are no longer applicable. Anything that supports a quicker response is important, so managing information in a format that’s easy to analyse and share – versus having to search reams of paper in a basement - has got to be a step in the right direction.

Next steps

Whatever technology companies may promise, regulatory transformation is not a shrink-wrapped solution that pharma organisations can buy off the shelf. This is a journey, and one that must start sooner rather than later.

The starting point must be to take stock – of existing system investments, existing data sources, and the scale of change users can be realistically expected to cope with. Getting buy-in to change takes time and should not be underestimated as a challenge, however much directors may be pressing for transformation.

Next, decide on and be clear about the goal. If this stops with compliance, that’s okay – but don’t sell the business short if you don’t have to. There is a great deal more to gain by looking for the bigger picture, not least an even stronger business case and ROI story.

Once you have decided on your end point, it’s time to plan the route. There is no universal approach that will suit all companies, so this will need careful consideration. The change programme is likely to involve a combination of consultancy, systems integration, and a degree of upgrading to existing infrastructure to add new functionality.

If approached properly, this is a journey that will take at least 18 months so the re-drawing of IDMP goalposts should not be taken as a chance to press the ‘pause’ button, deferring decisions until the fourth quarter of 2017! Far better that organisations use this time to develop a robust and well thought-out setup that they can have confidence in.

IDMP and transformational RIM is something new and unprecedented; there aren’t existing processes for this. So use the extra time to re-evaluate where you are now, where you are going, and what it will take to create a way of doing this that will see you through the next 10 years.


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Regulatory, IDMP, ISO IDMP, transformation, RIM, Regulatory Information Management

Siniša Belina

Written by Siniša Belina

Sinisa started his professional career at Pliva (now member of the TEVA Group), where in addition to his responsibilities in manufacturing, he also engaged in successful EDMS implementation project. Belina later joined KRKA’s Regulatory Affairs Department, and finally moved to AMPLEXOR. He applies his detailed knowledge of pharmaceutical documentation and processes to areas of business process analysis and optimization of EDMS.

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