Solving the last (or first!) mile of global RIM transformation: improving local affiliate engagement

by Steve Gens | May 10, 2023 | Blog

Tags:

At Amplexor’s BE THE EXPERT 2023 I will provide an exclusive first look at the most comprehensive global study to date of the evolving role of local affiliates in efforts to make global regulatory processes more dynamic and efficient.

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.
Steve Gens

Steve Gens

Managing Partner of Gens and Associates

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.