From talent challenges to labeling changes without an obvious justification: the view from Navitas’s Tris Nockles
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.
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Regulatory Industry Thought Lead at Navitas
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.