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The Data Relationship
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The Data Relationship
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BioPharm InternationalBioPharm International, Regulatory Sourcebook March 2022
Volume 2022 eBook
Issue 1
Pages: 20–22
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.
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As the world becomes increasingly data-driven and the need for standardization and transparency between the various sectors of the bio/pharma industry heightens, Europe’s implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) continues 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 companies, 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.
Read this article in BioPharm International’s March 2022 Regulatory Sourcebook eBook.
About the author
Felicity Thomas is the European editor for BioPharm International.
Article details
BioPharm International
eBook: Regulatory Sourcebook
March 2022
Pages: 20–22
Citation
When referring to this article, please cite it as F. Thomas, “The Data Relationship,” BioPharm International's Regulatory Sourcebook eBook (March 2022).
Articles in this issue
In-Use Testing of Cleanroom Garments
How a Lack of Critical Thinking is Hindering Regulatory Compliance
Contextualizing Computer Validation
Assessing the Quality of CAR-T Cells Using ddPCR
The Data Relationship
Supply Chain Considerations for Ensuring Quality
DSCSA’s Next Big Hurdle
A New Route to Pharma GDP Compliance and Standardization
Remote Inspections - Lessons Learned
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