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20 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com The Data Relationship As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively. A s t he world becomes increasingly data- driven and the need for standardization and transparency between the various sec- tors of the bio/pharma industr y height- e n s , E u r o p e 's i mp l e m e nt a t ion of t h e International Organization for Standardization (ISO) Identif ication of Medicinal Products (IDMP) contin- ues to progress apace under the European Medicines Agency's (EMA's) substance, product, organization, and referential (SPOR) programme (1). To learn more about the ISO IDMP and the way that data and documents will need to be addressed in the future for bio/pharma compa- nies, BioPharm International spoke with James Kelleher, CEO of Generis; and Frits Stulp, managing director, and Remco Munnik, associate director, both of Iperion Life Sciences, a Deloitte company. KEY DETAILS BioPharm: Could you provide some key details about the ISO IDMP standards and how these will impact bio/ pharma companies within Europe (as well as those seeking to do business in the region)? Kelleher (Generis): The ISO IDMP standards were designed to allow structured data exchange on medici- nal products. These standards will ensure consistency of data collected, enabling comparisons, traceability, and that updates to constituent parts are harmonized (for example, update on manufacturer or substance information). As with any such standard, there is effort required by all companies, small and large, in meeting it. EMA has pub- lished an EU IDMP Implementation Guide (EU IG) (2), with several updates, to guide along this process, but while it might seem an easy task, and a goal that will provide FELICITY THOMAS Quality and Regulatory Sourcebook Regulations: Data Integrity SunwArt - Stock.adobe.com