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IBSA is among the pioneers of regulatory digitisation

In the pharmaceutical sector, the regulatory function has the delicate task of ensuring that products and registration dossiers comply with increasingly stringent international regulatory standards. Certifying bodies – such as the European Medicines Agency (EMA), Swissmedic for Switzerland and the Food and Drug Administration (FDA) for the USA – require a rigorous and structured management of data and documents to support the effectiveness, quality and safety of marketed drugs and medical devices.

For pharmaceutical companies, this means facing growing challenges related to the organisation and security of information, which require increasingly sophisticated digitalised processes, in compliance with ministerial directives. In this context, in 2019 IBSA launched a significant regulatory digitisation project to optimise regulatory processes through the use of digital platforms. 

IBSA’S DIGITAL TRANSFORMATION IN THE REGULATORY FIELD

Angela Amato, Information & Regulatory Affairs Manager, explains how IBSA implemented this transformation, outlining the methodology adopted and the benefits obtained.

“Digitisation in the regulatory field aims to standardise and harmonise regulatory processes. Over time, in fact, the amount of data to be managed has increased significantly, creating the need to develop new processes to better handle this volume of information”, explained Angela.

Before implementing this project, regulatory processes were primarily paper-based, with all the associated limitations. “The old way of working was more burdensome, because it required handling paper documents and did not allow for an effective control of information”, added Amato. Today, the adoption of digital platforms is leading to a radical change.

Born from a global vision, the new platform allows real-time sharing of information and documents among different corporate resources and the various subsidiaries. Thanks to this approach, the IBSA Regulatory Affairs department can ensure each department and each subsidiary to have a rapid and simplified access to updated and standardised data, thus enhancing efficiency and reducing any margins of error.

BENEFITS AND FUTURE PROSPECTS

The results achieved through digitisation in the regulatory field are significant: greater operational efficiency, improved traceability of data and security and faster communication with Regulatory Authorities. Additionally, the new system also makes it possible to create and then make available data reports for various purposes, both regulatory and multidisciplinary, which provide a comprehensive view of data product, facilitating precise planning and monitoring of regulatory activities.

IBSA will continue to invest in digital innovation, focusing on advanced regulatory expertise and a continuous improvement approach, thereby contributing to the modernisation of the entire pharmaceutical sector, where security and traceability of data remain central to every activity.

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