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All things Pharma

All-digital regulatory affairs: three opportunities ripe for exploitation

What is the potential for transforming the management of marketing authorisation through the intelligent application of digital data capture and processing? ProductLife Group’s Erick Gaussens considers the possibilities for transforming the regulatory function and all-digital regulatory affairs.

When companies talk about digital transformation, they generally mean enabling greater information accessibility and knowledge exchange, and thereby enabling greater efficiency and innovation. One of the obvious candidates for digital transformation in life sciences is regulatory affairs – a function which must prepare data ad infinitum to get and keep products on the market. So what are the specific opportunities?

  1. Transforming regulatory relations

Although standards-based document templates and formats for electronic submissions have paved the way for more efficient data exchange over the last decade or more, efficiency gains will remain limited unless the data in those documents can be harnessed in smarter and automated ways.

With digitisation, as opposed to simple electronic document creation or scanning, the template of documents have built-in tags and links, allowing data to be ‘understood’ and processed by IT systems, reducing the need for human intervention – at least in the early stages of information retrieval or new document compilation.

It’s an opportunity that now extends beyond pharmaceutical and biotech products, too. Soon, extended data requirements will also apply to medical devices and combination products.

  1. End-to-end product visibility.

As original data, rather than the documents containing it, becomes the emphasis of regulatory information management, life sciences companies must ensure they have the means to manage and maintain the quality and currency of all of this data.

Increasingly, building and maintaining a complete set of regulatory information for the authorisation or lifecycle management of a product will involve data from multiple different databases, along a product’s lifecycle. The regulatory agency, meanwhile, will continue to build global databases for the manufacturer, the marketing authorisation holder, for excipients, and for ongoing pharmacovigilance.

Now more than ever before, regulatory information refers to almost all data about a marketed product. All of which has to be managed and maintained to a high level of detail and quality, and indexed and linked so it can be easily and accurately retrieved. All the data within these databases is linked and managed through metadata (ie the tags which help define, organise and locate data). Once the Identification of Medicinal Products (IDMP) set of data standards is in place, the expectation is that regulatory authorities will be able to look up any detail about a product.

These intentions shine a light on what’s possible more broadly for companies. If regulatory authorities stand to enjoy greater insight from, and ease in, product data handling in future, why shouldn’t life sciences firms themselves also benefit from the ability to call up any information about any aspect of a product and its current status – at any time, to support any purpose?

If that product information can be accessed and traced at any point in the manufacturing/regulatory continuum, so much the better. Functional information silos hold no benefit in the digital age.

As the likely data stewards, responsible not only for managing and finding data, but for understanding its broader purpose, regulatory affairs departments have an important facilitating role to play in all of this.

  1. Adding value for the business

Pure compliance projects are a costly and labour-intensive pursuit, so to restrict digital transformation expectations to meeting the needs of regulators alone is short-sighted.

Rather, digital transformation of regulatory affairs offers a chance for regulatory teams to add new value for their businesses. This could be by building a strong knowledge base of global regulations, timelines and opportunities for the portfolio, and applying data mining and artificial intelligence tools to help extract relevant and accurate data from websites to maximise the reliability and value of this resource.

Achieving a clear line of sight across a product’s market status, relative to evolving regulatory demands for a given geography, will help companies position their products optimally for market access. It’s through having this broader vision for digital transformation that regulatory affairs teams can turn compliance into something with strategic business value.

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Erick J. Gaussens
Erick J. Gaussens
ProductLife Group, Suresnes, France Erick is co-founder of ProductLife SARL, Principal Consultant and Chief Scientific Officer of ProductLife Group, a pan-European company specialised in consulting and outsourcing in the global regulatory field for life science industries, informatics, pharmacovigilance, clinical data management and regulatory compliance.


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