It isn’t just the pharmaceutical sector that is facing practical issues because of faltering data exchange and poor visibility. The medical device sector shares many of the same challenges, and these will prove increasingly critical as regulators impose stricter regulations around device traceability.
But effective data exchange isn’t just a compliance challenge in this sector either. As the digital health movement gathers momentum, the importance of having robust data trails will only grow. “Data integrity will be a major challenge—especially when it comes to connected medical devices involving remote measurements of physiological functions,” PLG’s Loetitia Jabri explained.
One of the growing issues for all life sciences organisations is the speed and frequency with which data can change and need to be updated across all departments and systems. Fragmented data chains and system silos create points of risk.
“The objective is to make sure we all use the same source of data,” Jesper Kihl of LEO Pharma said. “We recognise the potential benefit of having more integration.” Over the last year, LEO Pharma has updated its labelling practices, for instance, so that there is more end-to-end visibility and a seamless data flow. Having seen the positive impact this can have, the company is now looking at how to apply the same treatment to other parts of the business.
The objective is to make sure we all use the same source of data.
Lundbeck’s Jan Vindberg-Larsen noted that his regulatory affairs organisation has developed an effective infrastructure for collaborating more readily with production, allowing the two parties to share information more effectively. An SAP system is used for assessing all changes to products, including business cases; these are evaluated by commercial, regulatory and production teams before implementation.
The ability to work from the same data is also prompting broader collaboration. “We’ve also established a product committee for our marketed products,” he said. “The committee governs any major cross-functional activities and ensures alignment between regulatory affairs, production, and commercial operations on goals and priorities.”
It helps that modern software systems are now being built to be more open, in support of easier data exchange and process traceability.
Kelly Hnat of K2 Consulting noted that today’s RIM systems are very good at tracking changes to each change to a set of registered particulars about a product, the associated variation’s filing, and the approval status of that particular variation filing. “So you can see all of the changes to each registered data point in a RIM system if it’s managed properly,” she explained.
In the Gens 2018 survey, two-thirds of respondents said their companies expected to start to automate the regulatory-clinical connection over the next two years, while just over half said they would start to connect and automate regulatory supply release and product change control processes.