Building skills to power a data-first regulatory ecosystem


Director of Product Management, Amplexor Life Sciences, Slovenia


Most life sciences Regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorisation and variations submissions. Yet it is data, rather than pre-prepared dossiers, that is moving into central focus now. As the data-centric approach evolves, regulatory and product teams must review and refresh their skillsets so that they are prepared for new ways of working and able to derive the greatest benefit from a data-first approach to collecting, managing and communicating product information. Amplexor’s Renato Rjavec outlines a practical approach to developing the skills needed to meet the challenge.

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?


Given that this data-centric approach will be the new reality before long, the question for existing product information mana ...