Three reasons to digitally transform Regulatory Affairs
Erick Gaussens, PhD dissects how stronger information management can transform regulatory affairsAdd bookmark
Digital transformation in life sciences creates the opportunity for any authorised teams or individuals to connect to the fuller insights they need, on demand – which in turn can help to drive substantial improvements to productivity, and boost process accuracy and efficiency. One of the main potential beneficiaries of improved information management is Regulatory Affairs – a department which must collate, curate, quality-check and prepare data ad infinitum, to keep products on the market. Here, ProductLife Group’s Erick Gaussens considers the scope to transform marketing authorisation management; for large-scale data management; and for enhancing RA’s role in support of the broader business agenda.
1. A richer and more rewarding regulatory data exchange
Whatever the benefits of standard electronic data exchange in a regulatory context, unless contributing data is easy to extract and verify as the definitive, correct information, by the sender or the receiver, any efficiency and productivity gains will be limited.
Increasingly, organisations are recognising the broader potential if information compilation and extraction can be automated to some extent. This is what smart digitisation can help make possible. Here, document templates are encoded with the XML formatting, allowing 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.
2. Creating a definitive product data reference resource
As source data, rather than static documents, becomes the emphasis of Regulatory information management, life sciences companies must be able to manage and maintain its quality and currency.
As regulators’ demands increase, so will the range and scope of the data 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. Increasingly, 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, with implications 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. Functional information silos hold no benefit in the digital age.
As the likely data stewards, Regulatory Affairs departments have an important facilitating role to play in all of this.
3. Supporting the strategic business agenda
The days of disparate international regulatory submissions are fading fast. Regulators are demanding greater data consistency, and life sciences organisations are facing growing pressure to optimise complex portfolios across global markets. All of which requires coordinating based on greater intelligence and automation, so that each requirement is accurately and efficiently met.
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, built and harnessed using progressive technologies – including data mining (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 not only to better respond to international demands but also to position their products optimally for markets access, by quickly leveraging data that demonstrates the safety and efficacy of their products. By providing the business with pivotal intelligence, RA has an opportunity to raise its profile and in the process add a new and appealing dimension to the function and for the people who deliver it.