Building skills to power a data-first regulatory ecosystem

Stakeholders across the life sciences and healthcare ecosystem are increasingly realising that a data-first approach to collecting, managing and communicating product information will be the most efficient and reliable way to maintain a consistent, definitive, current and high-quality record of a product entering or on the market. One that can be interpreted and applied in a wide range of use cases, by the broadest possible range of people (from regulators to clinicians, pharmacists and ultimately patients).

Professionals in a range of roles are now used to converting their particular information e.g. about the medicinal product’s clinical properties, chemical composition or information for patients in the narrative or tabular form within the documents.

But are they ready to adopt new, more structured ways of dealing with such information at the source? Or is there an expectation that the Regulatory role will effectively assume the burden of data extraction and data entry assistance for them?