From chaos to control: Wörwag Pharma’s journey to structured regulatory information management
At BE THE EXPERT 2023 this month, I will chart the company’s journey to a ‘single point of regulatory truth’ and share some of the lessons her team learnt along the way.
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.
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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.