It can be so tempting to focus on the mandatory priority of new regulatory standards, but the shift from document-based regulatory submissions to something much more inherently data-based offers pharma companies a real chance to change their internal working practices for the better.

Implementing a good, holistic regulatory information management (RIM) system is becoming increasingly essential for pharma companies, because of the way regulatory processes will be managed in future.

But the scope for change is actually much greater, as companies look beyond compliance to the opportunities that arise once they have improved data quality and integrity; and as collaboration and communication (e.g. around change management) becomes much easier – once there is a centralized platform and there are agreed data standards.

Why stop at Regulatory Affairs?

The EU’s adoption of ISO IDMP data standards is the prompt all companies need to overhaul their internal processes. If, as an industry, we don’t embrace this opportunity, we risk missing out on a whole range of productivity and efficiency gains – not to mention the chance for increased market competitiveness.

At Sun Pharma, we’re extending the benefits of our investment to regulatory information management, pharmacovigilance and patient safety monitoring across the whole lifecycle of our products, using our Amplexor holistic RIM platform as the vehicle to track and manage all of this evolving information as it comes in.

It is important to be prepared for all the resources that will need to be allowed for in terms of time, technology and expertise, to properly plan and implement an effective end-to-end RIM platform, but the potential long-term benefits will more than justify this investment.

The view from here

Our own end-to-end RIM platform implementation continues. We had our first, technical go-live in December 2022 for the designated new applications, and we expect to complete our data migration phases by this coming December.

At BE THE EXPERT this month I’ll be talking through our experiences of our Amplexor deployment to date, from how we set our ambitions and scope for the project, to where we’ll be looking for the wider benefits – and how we expect these to translate into sharper market competitiveness.

It’s inevitable that complying with IDMP (not just in Europe, but in the US market too as the FDA embraces its own take on the standards) is going to add complexity – initially, in terms of the data transformation work that’s needed, and what that means for current processes. But the potential gains are substantial.

Having a centralized platform to track and manage everything definitively – data which by now is robust, consistent and reliable – will be an immense asset for pharma companies, from now right into the distant future. It will enable the different pharma functions to be sharper and more timely in their decisions and actions, which in turn will help them strengthen and enhance their market position.

I hope to see you at my session (or that you’ll view it online), where I’ll be going into more detail about our decision process, our implementation plan, and our hopes and expectations once we’re fully up and running on our new holistic RIM platform.

• Satappa Kambale, based in Mumbai, India, is a Regulatory & Business Continuity professional at Sun Pharmaceutical Industries Limited.
• At BE THE EXPERT 2023, he will discuss his company’s broader hopes for IDMP compliance and more structured regulatory data management, as Sun Pharma enters the final stages of its migration to a holistic RIM platform from Amplexor.

When Wörwag Pharma started out on its road to more structured and consistent global regulatory information management nearly five years ago, it faced an enormous task. With 1300 licensed products on the market, the data sets involved were vast, and much of this information was being tracked using Excel and SharePoint across highly dispersed systems around the world.

Like so many pharma companies, Wörwag Pharma was used to relying on a combination of Excel spreadsheets, SharePoint file shares and other ad-hoc combinations of systems to collate and manage regulatory information across its operations internationally.

Unsurprisingly, this created quite a chaotic situation when it came to creating regulatory submissions or tracking the latest status of a product, so in 2018 we embarked on a journey to bring order to all of our regulatory information management. This was no easy undertaking. We had around 1300 licensed products, making for a huge data set, and our goal was to gather all related information to create a single, structured point of truth for the entire organization. As well as regulatory information, this would include Quality data, especially around change control.

Eliminating everyday detective work

Our goal was to be more in control, to streamline our processes and reduce people’s workload so that these busy professionals could focus their time on more important work – instead of playing Sherlock, hunting down the latest information on a product or registration.

Five years on, using Amplexor’s holistic RIM platform, we’ve achieved exactly that. Although we’re still honing everything, we can now extract all of the relevant data we need for a particular product or task within just two clicks. That’s a huge transformation from where we were.

I’ll be discussing our journey quite frankly at this month’s BE THE EXPERT event, in the hope that other companies can learn from what we’ve done and accelerate their own transformations. We feel we embarked on this project at just the right time, but even if other companies aren’t as far along, I believe there is a lot they can do to optimize their outcomes.

Structure brings calm & control

For us, this has been a great opportunity to structure our data properly, which means we are now well prepared for Regulators’ evolving expectations – especially around IDMP-based data exchange. Before long it will be mandatory to submit machine-readable data to the authorities, starting with EMA. Because we are already most of the way there with consistent, rich and structured data, all we have to do now is “add the IDMP specifics” on top. If had been starting from scratch now, the rush to comply would have been much more chaotic.

That isn’t to say that other companies should panic. My main note of caution would be not to rush out and procure a “quick and dirty” solution. Even if time is an issue, it’s still critical to define your requirements and be clear about what you, as a company, will get out of a new RIM platform, beyond regulatory compliance. For instance, that could be reduced time searching for the latest information; better use of people’s time; and the ability to call up an overview of all products and their components within seconds.

Structuring all of your data ahead of time, certainly as much as possible, is strongly recommended. Fortunately, Amplexor has some good tools to help with that, as well as best practice advice distilled from other projects: for example, about how and where to start, and how best to manage the transition.

Of course, no project runs 100% to plan, and I’ll be focusing not just on what went well for us, but also the hurdles we had to overcome and how we did that. Hopefully, this will help other companies avoid repeating the same mistakes and accelerate their progress towards their own end goals.

I look forward to what I hope will be a useful, interactive session.

• Dr Henrike Miess is Senior Manager Regulatory Affairs at Wörwag Pharma in Germany.
• At BE THE EXPERT 2023, Dr Miess will discuss how Wörwag Pharma managed its transition from, in her words, “chaotic” regulatory information management (using Excel and SharePoint, across dispersed systems globally) to something much more structured and efficient, using Amplexor’s holistic RIM platform.

Waiting for regulators or software vendors to come up with the definitive rulebook for all future data reporting requirements is a bit like waiting for a tax-office request to trigger accounts management. There will always be new compliance goals, but the real opportunity is about making good data work harder time – something Life Sciences companies could – and should – be doing right now.

The fact that Life Sciences is adopting and seeing value in structured data is a huge turning point for the industry. And, once companies can see beyond the demands of the regulations that are helping to drive this, the opportunities will truly broaden so that they can transform everything they do.

This is about so much more than adhering to the specific requirements of IDMP, ePI, CTIS, ESMP, PQ/CMC and associated global implementation projects. It is about having good-quality data which significantly improves internal and external processes – with a view to identifying new market openings, optimizing clinical trials, shortening time to market, eliminating product shortages, and managing labelling changes seamlessly and without fuss.

It’s something I’ll be delving deeper into at this year’s BE THE EXPERT event in Split.

As well as bringing us all up to date with the very latest on IDMP and other data-based requirements affecting key aspects of the R&D and marketing authorization/post-marketing product lifecycle (including safety surveillance and license maintenance), I’ll be looking more closely at some of the bigger opportunities that companies have now to transform the way they operate. This includes the way they track products, tap new market potential, and connect with and add value for clinicians, caregivers, prescribers, payers, and – of course – patients.

Stop reinventing the wheel

Taken individually, the various mandates and required data capabilities and systems, can seem daunting. Take the new European Shortages Monitoring Platform, expected to go live within two years. It’s been conceived by the European Medicines Agency (EMA) in the wake of COVID-19 related supply chain disruption and shortages – not just of immediate vaccines and treatments, but of other critical medicines as entire countries and regions went into lockdown.

The new data-driven platform is EMA’s response to the situation, intended to pre-empt and curb unexpected supply issues – whether these involve paracetamol, antibiotics, flu vaccines, or hormone replacement therapy products – through prompt reporting of emerging issues.

While functional managers and IT teams might balk at yet another reporting requirement, once companies are generating regulatory data, as captured currently in documents, they can do so much more with it. This is of value to the MAH in its own right – not just because it is a regulatory mandate. It makes sense, then, to make the best possible job of capturing and maintaining that data, to a consistently high standard.

Once companies have captured the relevant data, the next step is to structure it in such a way that it can be exchanged reliably with other systems, both internally and externally. Instead of requiring that new manual processes are invoked to enter the latest relevant data into a new system or portal, that information should pre-exist and be readily redirectable to fulfil each additional emerging need.

Ultimately, gaining visibility of potential product shortages requires simply that product data and supply chain information can be combined to provide, compile and report the relevant insight.

Tracking tangible progress

In my session at BE THE EXPERT, I’ll be walking through a range of new use cases that could be enabled relatively easily once companies have reliable, consistent, good-quality, structured data organized and ready to go.

In other words, once all of the contributing insights have been released from static PDFs (e.g. CMC manufacturing process and control information as submitted to regulators in Module 3) and exist as live intelligence that can inform other teams and fulfil new reporting demands. For instance, visibility of how many products have a certain excipient, and where a product is manufactured, could automatically flag up emerging supply issues out of China, India or any other country, if that country is in lockdown.

In my discussion, I’ll be focusing primarily on the latest developments in the EU, though I’ll also run through the latest significant moves towards data standards (especially IDMP) in other markets – including Switzerland and the US.

One message I really want to drive home is the need for Life Sciences companies to move forward with all of this with a renewed sense of urgency now. Given the broad opportunity for process transformation, and the potential for crucial new actionable insights, there is absolutely no excuse for any pharma company to be sitting back and waiting – whether that’s for Regulators to issue final instructions, or for software vendors to have exactly the right capabilities in place.

Although there may be some finer details to be ironed out, there is a LOT of groundwork companies need to do today to get their data in shape, and that needs to be happening right now.

In other words, getting control of internal data should be an absolutely priority for all companies. Certainly, talk to your tool vendor about what that might look like, but relying on regulators or the software industry to lead from the front is not the way to approach this.

It’s a bit like starting to do your book-keeping only once the Tax Office has asked you to submit your tax declaration – when really you should have been recording everything throughout the year. Why persist with the 11^th-hour panic, when reliable on-demand reporting is possible today – with appropriate attention to data capture and management?

I look forward to fleshing out these themes with you in person.

• Remco Munnik is a Director at Iperion – a Deloitte business. As well as being a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP, Chair of Medicines for Europe Telematics group; and President of the IRISS Forum.
• At BE THE EXPERT 2023 in a session entitled, The implementation of structured data and opportunities for optimization, Remco will outline the latest developments on global implementation projects for structured data (e.g. IDMP, ePI, CTIS, ESMP, PQ/CMC, etc) and the opportunities that pharmaceutical companies have to leverage these upcoming requirements to improve internal and external processes.
• Remco will also be participating in a panel discussion, on the subject of Empowering Efficiency Beyond Technology, with a focus on the role of data governance and the need for clear data roles and responsibilities as companies enrich their information assets and make them more reliable and readily reusable.

Most companies have made global RIM adoption a strategic priority, and improving affiliate engagement – to achieve a high-performing regulatory organization with high data quality – is paramount to achieving this goal.

Yet transforming information management across this last (or arguably first) mile of the internal regulatory matrix has been notoriously tricky up to now. Highly manual processes, specific local market requirements, not to mention language differences, have often meant a gap in information visibility at a central level – and a hiatus in completing key processes.

So how far have companies come?

What a difference 8 years makes

Gens & Associates began tracking affiliate developments as part of its Global RIM research as long as eight years ago. And, by the time we meet in June, we will be a month into an unprecedented study of local affiliates representing each corner of the globe, and the key achievements and barriers as perceived by these on-the-ground representatives.

In the first half of May, we launched the largest ever local affiliates study in regulatory – which will include responses from a minimum of 350 local offices, from a pool of 18-22 sponsor companies each with 15 to 25 contributing affiliates of different sizes and geographic locations.

We’re keen to explore what’s going on at the affiliate level in the creation and management of all this vital regulatory information that global companies are working so hard to bring under control. We’ll be looking at how far the adoption of global systems and processes has extended over the last few years, and how much is still now at a local level.

Although, when we started looking at this topic in the 2013-2015 timeframe, we weren’t looking as broadly as we are today, we were able to build a picture across about 65 countries of how companies were managing their regulatory information – pretty much right from the start of the whole push toward a global system and ways of working.

This has given us a baseline which we’re able to compare against now. For example, eight years ago, around 88% of local affiliates were recording and managing regulatory information in Excel, SharePoint and other local file shares – compared to just 12% who were doing this in a global system.

By the time of BE THE EXPERT in June, we’ll have some preliminary data and some strong indications of the current status, the achieved levels of efficiency, and most importantly – the opportunities.

The goal, of course, is to improve global regulatory information management – to make it more efficient and effective. And, by the time I meet with you to present the preliminary findings, I expect to have the top-level findings across some 40 and 60 affiliate organizations, ranging from small to large. We’ll also be able to make some regional comparisons, looking at how Asia-Pacific companies are doing versus the Americas, for instance, or in comparison to Europe and the Middle East/Africa.

Close, but no cigar (yet)

The results are going to be very comprehensive. That’s not least because we designed the study in partnership with industry, and also with some of the key regulatory providers, to ensure the ability to test anecdotal observations on a more scientific/statistically-relevant basis. For each company that’s participating, the survey results will provide the voice of their affiliates too, which will be very illuminating – and the fact that we can roll that up to a macro level.

My expectation is that the affiliates will still tend to be behind the curve on global RIM adoption. That’s largely because – any time that you make a big change – there will be a series of very small changes over the ensuing years to optimize processes, and the system. And that’s what we’re seeing now, as affiliates get up to speed.

I’ll also share some of the 2015 data, as a reminder of the daily complexity at the local affiliate level – the degree of reliance still on local and regional tools versus this massive investment now in global regulatory information management systems. We’ll dig deeper into the engagement between the central and the regional office, too, exploring how that is going and how it might be improved to enable more fluid collaboration.

In addition, we’re asking affiliates to rate the efficiency, and the effectiveness and usability, of all of these new global systems – how it’s going for them, and how much is still under their remit, for instance.

Candid feedback – from all corners of the world

My suspicion is that local affiliates are still tracking a lot of the information held in global systems locally; that there remains a disconnect with real-time local regulatory information and regulatory intelligence – the input needed for global dossier management.

It’s going to be a big eye-opener, certainly – not least because we’re asking each local affiliate to tell us the one thing that could improve their overall performance with the management of regulatory information, as well as how they’re generally experiencing central global systems to date.

As we go deeper into the findings, we can expect to see evidence of renewed efforts to reduce the time to submission and approval of new products, or extensions in international secondary markets, through improved global dossier management.

There will be a lot to discuss in this data-packed session – I hope to see you there!

Please click here to register for this year’s Be The Expert Live event in Split, Croatia!

• My session at BE THE EXPERT 2023 – Global RIM Adoption – Improving Local Affiliate Engagement – will review the latest Global RIM Benchmark and distil how, in 2023, affiliates are interacting with headquarters at a process, system, data quality, and organizational levels.
• Key learning points will include:
  • The affiliates’ perspective on how they can be better supported within their functions;
  • Remaining barriers for collaboration and engagement with headquarters, and
  • Opportunities to improve process and system efficiency.