As 2022 wraps up, we asked those in the know about the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.

Here’s what Renato Rjavec, Director of Product Management at Amplexor Life Sciences, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

Beyond running their day-to-day operations, I believe Regulatory teams need to focus the majority of their efforts on the transformation from a content- to a data-centric operational model.
DADI is already providing an imminent touchpoint with regard to IDMP requirements and, if companies aren’t already at the beginning of this pivotal journey, or don’t at least have a sound plan for it, they won’t be on the right path to having efficient and scalable Regulatory operations in the years to come.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

Regardless of its limited initial implementation scope, DADI will evolve and, in due course, present additional data submission requirements from the industry. The most impactful milestone on the IDMP journey will be the transition from XEVPRM to the FHIR data submission format.

Although there are high chances for further delays – and nothing will happen overnight – such a transition will take time to implement. It’s essential then that Regulatory has a sound strategy and long-term plans to establish a solid foundation for the upcoming requirements, before these are implemented.

On the other hand, the tactical aspects of the implementation needs to remain agile so that they’re able to adjust to any uncertainties related to scope, timelines, and technical details.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

Those who may still be addressing emerging data submission requirements with a patchwork of temporary or partial solutions will find they face more and more challenges over time. Ensuring that their end-to-end RIM platform is ready for the data-centric future, while supporting the IDMP requirements, should be at the top of their priority list.
We recommend companies take into account the following critical factors when selecting a suitable platform:
• A data-centric design at the core of the platform, so that data can become a key asset for the organization;
• Data quality controlled at several levels, to ensure compliance and business efficiency;
• A user experience that’s based on built-in business rules and automations, enabling a user-friendly efficiency with each use case;
• Connectivity providing for seamless internal and external process and data flows; and
• Flexibility, making it possible to adapt readily to evolving regulatory and business requirements.

About the author

Agnes has been in the position of ALSS Head of Product Management and
Consulting since May 2017. Her main responsibilities are the contribution to
the development and enhancement of the Amplexor Life Sciences Suite,
supervision of the Life Sciences Consultants as well as the provision of
business process and data management expertise to Amplexor clients in
Regulatory Information Management, Document Management, and
Submission Management. 

As 2022 wraps up, we asked some of our revered industry partners and popular BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.
Here’s what Tris Nockles, Labeling Networks Lead at Navitas Life Sciences, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

The single biggest issue, if we can boil it down to that, is how to drive efficiency amid a complex and shifting environment. Regulatory Affairs is on the front line to deliver submissions in increasingly condensed timeframes. Many companies have ongoing projects to consider how to optimize the submissions process, yet the challenge facing the industry is so much broader than just the “How” and the “What”.

Finding talented people with the right skills to come and work in Regulatory has historically been problematic, and seems to have become a more difficult and lengthy pursuit in the last few years. The 2022 labelnet benchmark shows that it takes between 6-12 months (from posting to contract signed) to recruit mid-level and senior staff.

On top of that, technology is under-delivering on the promise of truly end-to-end, user intuitive, automated systems in the Regulatory space. It is not uncommon for companies to augment their RIM capabilities with more friendly technologies to capture and feed data in, or look to flexible resourcing to enter data on behalf of their Regulatory staff

So, while companies are using workarounds, surely solving these problems is key for driving efficiency in Regulatory.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

The drive to deliver submissions more swiftly will only increase and become more widespread. Accelerated submissions and approvals during COVID-19 have created an aspiration for senior industry leaders that will only increase, and the question is whether Regulators have a similar appetite.

The labor market is only likely to become more competitive with people continuing to make different lifestyle choices, although global recession and cost of living challenges may result in people re-entering the workforce, particularly as companies look to retain more flexible working policies.

The technology landscape will also need to adapt. Although progress is slow, Regulators are showing interest in a more data-centric approach moving forward, which will challenge the current paradigm of document-centricity. How long before, and whether we will ever get away from document submissions completely, remains to be seen. But technology vendors may want to consider this in their future development pipelines.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

While companies still have the dilemma of their internal staffing model, flexible resourcing could offer some respite. The 2022 labelnet benchmark showed that 95% of companies are leveraging outsourced resources for operational tasks and, as they build close partnerships, some are looking to expand that model with activities related to their established product portfolios. Companies that are not outsourcing often pursue an off-shoring approach or a hybrid model.

Companies are also working closely with academia to build the talent pool at an earlier stage, collaborating with PharmD programs and institutions, through fellowships and internships, to build skills and experience – with the aim to have those people return as future full-time employees.

Many companies are also looking to technology to streamline workload for the future. They are actively asking vendors to build automation into their RIM solutions. Some are pinning their hopes on structured content management, collaborating closely with vendors to build out the Regulatory use cases.

What’s next for digital labeling?

The digital labeling environment is a mixed picture globally but there are some real hot spots emerging. The EMA is developing the technology to underpin the ePI common standard, and has a minimum viable product planned for a limited pilot in 2023, with a phased and flexible implementation to follow. This is in a shared workstream with DADI and SPOR, and the hope is that in future data will be interoperable across these platforms.

Pilots continue to proliferate, and some countries have accelerated the conversion into formal regulations, notably in the Asia-Pacific region. Expansion is particularly prevalent with regard to hospital-only products, and this is where there are a number of expansions in the EU. Another potential opportunity could be to consider the model adopted by Norway with extended implementation timelines where digital labeling is available.

Apps and blockchain continue to offer options for the technical delivery of patient information but, mirroring national competent authorities, there is not a visible willingness to align on a single solution. This means patients and healthcare professionals could be facing a situation where they need a myriad of apps simply to be able to effectively manage their healthcare. Scanning codes on packaging appears to be a preferred option moving forward and, with an appropriate education program, this could be beneficial in ensuring patients are accessing the most up-to-date information.

Digital labeling continues to seek the compelling imperative for change. If we consider parallels where digital platforms are increasing their digital presence, it has often been triggered by a specific “black swan” event or at the behest of the end users. We didn’t know we needed digital banking or even social media 20 years ago, but now for many of us these are routine in our lives. Although some advances have been made in moving healthcare online, adoption is still in patchy and typically more with the technologically-adept. Until patients start to demand the change, the catalyst remains unclear.

To stay ahead, I recommend that companies find and leverage strong cross-industry networks. The effort involved in keeping up to date and understanding learnings from pilots can be overwhelming if you are trying to do it alone. Participating also has the benefit of connecting with industry representatives who have a seat at the table with the regulators to provide a strong, aligned industry position or perspective.

About the author

Tris Nockles has been leading the Navitas Regulatory Industry Networks for the last two years, with 18+ years of industry exp in Life Sciences, Devices & Consumer Products.  She specializes in strategy, process improvement and development initiatives focusing on Regulatory, E2E labeling & RIM. Tris is located in the UK, and is fortunate to live near the coast where she loves to walk on the beach with her partner and her three dogs.

As 2022 wraps up, we asked some of our revered industry partners and popular BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.
Here’s what Kelly Hnat, IDMP/SPOR and business process/program management expert at K2 Consulting, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

For me, the main challenge that Regulatory organizations face now is how to establish complete and accurate structured data representations of their registration information – and manage it in a meaningful way. We’re in the midst of a kind of a revolution in regulatory submissions at the moment, and it’s changing everything about how we need to look at, manage, think about, and share data across pharma organizations.
I liken it to the changes we saw when eCTD was implemented – all the contributing functions and regulatory were impacted, and we needed to re-educate ourselves about how to operate in a new paradigm. At that time, the change brought some far-reaching benefits and improved quality and efficiency in how submissions were produced. In a similar way, the current advance toward structured data and new submission paradigms will have benefits for Regulatory, and across the enterprise, as we begin to tap the value of clear, accurate, and complete data representations of registered medicinal products.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

Many, if not most, organizations are already well into preparations: implementing or updating their registration systems, thinking about how to integrate those systems effectively across the enterprise to effectively share data, and about what business processes to establish to get this all to work.

But there has been a bit of a reprieve with the changes in the EMA strategy – from the previously expected requirement to prepare SPOR FHIR messages, to the focus on the new DADI electronic application form replacement – so the runway has grown a bit longer.

For most organizations this is good news – because this change is much more challenging than many organizations understood when they started planning their implementation programs. Over the next year these implementations will continue and, for those companies which are a bit further along, we’ll start to see how the various implementation approaches play out in production – and have a chance to learn from the successes and challenges that result.

The main thing that organizations need to watch out for is not over-engineering their solutions. In the mid-to-late 2010s, a lot of people thought that the key was to flow data in some automated way from supply chain and other systems to create the IDMP datasets.

On the face of it, this is a logical way to approach it: components like manufacturer information; formulation details; and packaging hierarchy are created and changed in tech ops and supply chain, and that data sits in ERP and BOM data sets – so let’s just use that! The problem is that the data in those systems is created and maintained to support the manufacturing and distribution processes (producing what is approved), and that is fundamentally misaligned to regulatory processes (proposing what should be approved).

That leads me to what I think the main watch point should be for all organizations – that structured regulatory data is only partly a technical problem. Mostly, the challenge ahead is a business process problem. Most of the commercial registration management systems have long had the ability to capture and manage the data we need to structure, and I believe if we establish the right business process around that, the solution can be quite straightforward.

It then becomes a problem of getting people to change how they work. Again, I draw the parallel with eCTD: then we had to change how authors worked with technology. Now we need to change the way our Regulatory product teams work with technology.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

In addition to what I’ve already mentioned, I think Regulatory needs to be sure it is setting its sights beyond its own borders – both in how data is collected and created, and also in how and where it is consumed.

The main benefit of the structured regulatory data future is what this data can be used for. And Regulatory Affairs will not be the only consumer of this new, deep, accurate and complete set of data that is coming into being. This information will have great value across the enterprise – for Supply Chain, Commercial, and beyond.

We use systems for two reasons: first, to enable a business process; and second, so we can make business decisions based on the data they contain. I’ve always felt that we should design our systems with the end in mind. In other words, how can the information we collect and manage be consumed to support business success?

Thinking about the key potential consumers of data will help build its value beyond the regulatory compliance use case, and shift Regulatory’s role within the enterprise as a data producer.

If you could convert one misconception, or make one breakthrough, to change companies’ thinking and plan of action for 2023, what would it be and why?

It’s critical that organizations do not rely on the technology to solve their problems – technology is only a tool. The key to success is always going to be manifested through business process and organizational culture.

Many perfectly good registration management systems are seen as a failure within organizations that have not taken the time to establish the processes and organizational support for them to be successful. When the data is then poorly managed and becomes untrusted, it’s seen as a failure of the system and the software vendor – in which case the expected solution is to replace the system.

But the business process and organizational components are the actual foundation for success – in our research with Gens & Associates over the year, we’ve consistently found that there is no correlation between top-performing companies and any one software provider or system strategy. Top-performing organizations excel at the process and organizational work, along with strong implementation execution. These strengths can overcome the weaknesses with almost any software platform… but the opposite is never true.

About the author

Kelly Hnat is a leader in RIM and IDMP with over 25 years’ experience in the biopharmaceutical industry leading IT, RIM, and Regulatory Operations organizations.  Kelly is a globally recognized expert in IDMP and is a key subject matter expert supporting the EU implementation of IDMP as a member of the EMA SPOR Task Force, the SPOR PMS sub team, and the SPOR EU Implementation Guide Focus Groups.  Additionally, she is a member of ISO TC215/WG6, is a member of the Core Research Team for the Gens & Associates World Class RIM survey, and serves as President/CEO of IRISS Forum, a global nonprofit organization that brings together industry, vendors, and health authorities to address topics related to submission standards.  Kelly leads K2 Consulting, a boutique consultancy that provides business process, organizational strategy, and technology strategy services for Regulatory Affairs organizations.

As 2022 wraps up, we asked some of our revered industry partners and popular BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.
Here’s what Remco Munnik, Associate Director at Iperion – a Deloitte business, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

In my opinion, Regulatory has always been the spider in the web within a pharmaceutical company – collecting all of the relevant information for submission of the registration: Clinical, CMC, administrative data, etc. And then it faces the time crunch, to compile all documents into a valid eCTD by the submission deadline. Up to now this process has always been very document driven.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

The biggest challenge ahead is that data should become the leading source, and the content of documents must then align with that data. With EMA’s direction now toward agile development, pharmaceutical companies too must become agile – in terms of adapting their own processes and systems. The biggest challenge ahead is for companies to become more data-driven organizations, and to adapt complex processes and transform the content from large volumes of legacy documents into more dynamic, resuable data.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

I think it’s really important that companies reset their strategy now, moving away from document-oriented information delivery activity toward data-driven ways of working. An overall company strategy would benefit such initiatives significantly. In addition, it’s crucial that companies implement an agile way of working now, given the huge task ahead. This is about moving forward with small steps, making real progress overall and determining how things can work more efficiently.

Even if you can’t name the company, what is the best examples of advanced content/data management you have seen in life sciences recently, and what trajectory is that company now on? i.e. what benefits will it start to see, and how soon?

One company that we supported linked its RIMS (Regulatory) and ERP (resource planning) systems, allowing it to connect two worlds of data and enable reporting of key information. For instance, “Can a product from country X be sold in another region?”; “Which manufacturers are actually used?”; and “How long does it take to implement this type of variation in production, based on past experience?”

To identify use cases, structured data is key and should benefit companies’ daily activities. That is, data-based initiatives should be much broader than a “compliance” project, and be more strategic in outlook.

If you could change one aspect of most companies’ plans or thinking about data and document management for 2023, what would it be specifically? What one action should they take next to recalibrate?

This would be around the impact that the new web-based electronic application forms (eAFs) will have on Regulatory processes. Data is going to be tied in within the regulatory process of product assessment. Companies should get their data, system, governance and processes in place for this.

About the author

• Remco Munnik is a Director at Iperion, a Deloitte company. He has more than 20 years’ experience in Life Science and Regulatory Affairs, including more than a decade providing consultancy around Regulatory Information Management (RIM) and electronic submissions. He is a respected subject matter expert in RIM, eCTD, xEVMPD and ISO IDMP.
• Remco is also an active member of EMA ISO IDMP Task Force Organizations and Products; Chair of Medicines for Europe Telematics group; and Vice-President of the IRISS Forum, a global, open, multidisciplinary, non-profit networking organisation for life science professionals by life science professionals. One of Iperion’s widely-acknowledged strengths is its deep networking with stakeholders across life sciences – including regulators, software vendors and customer groups.

As 2022 wraps up, we asked some of our revered industry partners and popular BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and to predict the most prominent themes and priorities for 2023.
Here’s what Steve Gens, managing partner of Gens and Associates, had to say.

What, for you, is the single biggest issue of importance in relation to the Regulatory function right now, and why?

Improving global ways of working, to decrease the time for market approvals (that is, the time from first to last market submission), has been the biggest area of focus and progress.

Biopharmaceutical companies with Covid19 products (vaccine or therapy) were able develop and gain regulatory approval in records time. Never in our history has getting products to patients been so critical, and there were new approaches developed to accomplish this (as measured in Gens & Associates’ 2020 and 2022 Covid19 Regulatory Impact studies).

This has led to new ways of working, increased application of modern technology and digitization, and good old-fashioned process enhancement (change control, label management, regulatory intelligence, etc) at an end-to-end level.

How do you see all of this playing out over the next year – and beyond (eg. 3-5 years ahead) – and what do companies need to watch out for?

Companies that are modernizing their regulatory information management program now are focused on evolving the regulatory operation organization driven by the data sciences, and also the application of advanced technology. This includes robotic process automation, structured content generation, and connectivity to other critical functions such as Quality, Manufacturing, Safety, and Clinical.

What do you see as being the main facilitators? In other words, where do companies need to focus their efforts now, and what decisions/actions in particular will be important in determining how well they do?

Companies need a clear digitization strategy, in conjunction with other functions (e.g. R&D, Manufacturing), as well as improved information exchange at a local affiliate or “last mile” level where further innovation is required.

These two factors will greatly enhance both the efficiency and effectiveness of the Regulatory organization.

As soon as we look beyond the immediacy of the Regulatory function, the picture shifts for data management and its potential. What excites you the most in terms of what could be possible and how far this could go – and what might that look like?

We are in the early stages of the “data connectivity” period, where critical data from various functions (Regulatory, Quality, Manufacturing, Safety, Clinical, etc) are gradually being connected.

This requires a clear focus and excellence around cross-functional data governance, and on ensuring all data from all these various systems is at the same high level. The goal is to achieve sufficient confidence in data quality to directly impact productivity and facilitate more effective decision-making.

This is where the promise of cross-functional business analytics, real-time information visualization, and advanced technology will play out. What we’re witnessing is the birth of the data science era.

When you look across your surveys, including the most recent findings, what frustrates you most in terms of what companies still haven’t realized, or still aren’t doing – and what should they do differently in 2023?

This one is simple: companies need to become better at central, regional, and local affiliate collaboration and information management. Lost opportunities persist when it comes to improving how real-time regulatory information is available globally, to support day-to-day operational tasks across different markets. On top of that there is substantial untapped scope to strategically improve the “time to patient” for new products – especially in the smaller markets around the globe.

Improved regulatory intelligence sharing; global dossier management excellence; and the central organization working more seamlessly with the local affiliate will be critical success factors.

About the author

Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., A Life Science benchmarking and advisory firm specializing in performance improvement, strategy, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

 His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named to the 2017 PharmaVoice 100 and as an innovator in the 2021 Innovations in Pharmaceutical Development™ for his contributions to industry.