Digital empowerment & Regulatory Affairs: why bother?

Whatever the industry, digital transformation creates an opportunity for teams to connect to the fuller insights they need, on demand – which in turn can help to drive substantial improvements to productivity, accuracy and efficiency.

One of the main potential beneficiaries of improved information management in life sciences is Regulatory Affairs – a department which must prepare and manage data ad infinitum, to keep products on the market.

Here, ProductLife Group’s Erick Gaussens sets out three persuasive reasons why RA teams should champion the digital transformation agenda.

1. A richer and more rewarding regulatory data exchange

Increasingly, organisations are recognising the broader potential if information compilation and extraction can be handled not just electronically, but in an increasingly automated way. This is what smart digitisation can help make possible. Document templates encoded with XML formatting allow linked, live data to be lifted from databases - reducing repetitive manual data re-entry and scope for human error and delay. Meanwhile checks can all happen in one main place.

It’s an opportunity that extends beyond pharmaceutical and biotech products now too, as regulatory data requirements are extended to medical devices and combination products.

1. Creating a definitive product data reference resource

It’s data rather than individual documents that matters now. As regulators’ demands increase, so will the range and scope of information firms will need to manage, spanning diverse databases - from clinical to toxicology, and so on. The same applies to the Regulatory agencies keeping track of everything. Regulatory information is coming to include almost all data about a marketed product.

To ensure that related information can be connected and extracted easily, data must be linked and managed through metadata (ie data about data). Once the ISO Identification of Medicinal Products (IDMP) is live, the regulatory authorities should be able to pull out any data relevant to a product.

This shines a light on what’s possible for companies themselves. 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.

1. Supporting the strategic business agenda

The days of disparate international regulatory submissions are numbered. To improve data consistency, and allow life sciences organisations to optimise complex portfolios across global markets, the emphasis is shifting towards coordinating fuller intelligence and creating this using more automated approaches.

This coordination effort presents an opportunity for RA teams to add value for their businesses, by building a strong knowledge base of global regulations, timelines and opportunities for the portfolio. A comprehensive resource of the latest regulatory intelligence, which has been built and is harnessed using progressive technologies. These might include data mining solutions (to extract data from websites), natural language processing (to ‘read’ it straight into systems), artificial intelligence and machine learning (to process it in meaningful ways, at speed), and rules-driven process automation - to expand the capacity and accuracy of regulatory intelligence.  

Expanding regulatory intelligence will enable companies to position their products optimally for markets access. By providing the business with pivotal intelligence, meanwhile, RA has an opportunity to raise its profile and in the process add a new and appealing dimension to the Regulatory function and for the people who deliver it.

Erick Gaussens,
ProductLife Group
www.productlifegroup.com