Erick Gaussens, ProductLife Group’s chief scientific officer, reports on a recent pharmaceutical roundtable which examined why streamlining data management between regulatory and manufacturing needs is a pressing concern for manufacturers.
Data
Maintaining separate information systems to manage product data no longer serves life sciences firms. Compliance, cost-efficiency and improved agility depend on building closer links between enterprise resource planning (ERP) and regulatory information management (RIM), and reducing the number of separate instances of the same information being captured, stored and updated.
On the panel were:
- Steve Gens, managing partner, Gens & Associates
- Kelly Hnat, principal, K2 Consulting
- Jesper Kihl, VP for global regulatory affairs, LEO Pharma
- Jan Vindberg-Larsen, senior director and head of global regulatory affairs, Lundbeck
- Erick Gaussens, chief scientific officer, ProductLife Group (PLG)
- Catherine Gambert, senior consultant for regulatory affairs and regulatory information, PLG
- Loetitia Jabri, regulatory and pharmaceutical platforms associate director, PLG.
Noting that product and regulatory information has an ever greater role to play in the efficiency and strategic direction of life sciences businesses, the debate panel considered how companies could make more of this.
In Gens & Associates’ latest market research into companies’ regulatory information management (RIM) activities, the improvement of data management and connections to other functional areas is now a major priority. Yet, many firms are held back by the scale of change to processes and systems involved, Steve Gens noted.
But they have little choice now. As things stand, just 14% of companies have connected RIM and enterprise resource planning (ERP) systems. Most information gathering and verification still happens manually, creating a huge data management burden and scope for business risk.
If information about a change control process doesn’t flow between regulatory and manufacturing, for instance, it can cause hold-ups in international markets. As PLG’s Catherine Gambert warned, “When a product gets stuck at the border because the information printed on the box isn’t the same as that in the regulatory documents, it becomes a serious issue.”
In the medical device sector, data quality and consistency will prove increasingly critical too, as regulators impose stricter regulations around device traceability, and as the digital health movement gathers momentum, PLG’s Loetitia Jabri noted.
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.
“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. It is now looking at applying the same treatment to other parts of the business.
At Lundbeck, the 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,” Jan Vindberg-Larsen 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. In 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.
Reduce, review, repurpose
An increasingly popular approach to streamlining data management is ‘master data management’. Here, the emphasis is on creating and maintaining a single, reliable record of the product truth, which can be repurposed in multiple different ways by different teams, as needed.
When a company treats data as a corporate asset and maintains it in the form of definitive master data, the whole organisation stands to benefit, the panel agreed. Jesper Kihl, explained how his team at LEO Pharma has used the broad demands of IDMP to highlight the fuller potential for greater efficiencies and closer connection between functions.
Down the line, a more joined-up approach to product data promises to make everyone’s life easier, makes processes slicker, and drives out cost and risk, while supporting greater market agility.