2022 | November / December 2022

Building skills to power a data-first regulatory ecosystem

by cyb2025

RENATO RJAVEC
Director of Product Management, Amplexor Life Sciences, Slovenia

ABSTRACT

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).

Login