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Veeva R&D Summit

12-14. juni | Barcelona

NNIT udstiller og præsenterer på Veeva R&D Summit 2018.

Veeva R&D Summit er et årligt arrangement, der samler pharma, biotech og medical devices & diagnostics ledere i clinical, regulatory, quality og it.​ Agendaen har dedikerede spor, der fokuserer på at drive end-to-end forretningsprocesser på tværs af produktudvikling.

Læs mere om konferencen her.

NNIT's Kianoosh Khaksar præsenterer på Quality-sporet med præsentationen: “Data Integrity: A Holistic Approach".

Præsentationsbeskrivelse (engelsk):

While data quality and data integrity are related, they are independent: you can have one without the other. Increasingly, regulators have a focus on data integrity, latest with MHRA's guidance on GxP data integrity (March 2018), where requirements to data's life cycle are made explicit.

However, requirements to data quality are just as important, but not so explicit - even good practice descriptions like GAMP does not define data quality. Yet, most pharma companies struggle with data quality issues and the consequences may be severe, both in terms of internal complications and regulatory compliance.

This talk will therefore discuss the requirements to data quality as a quality management activity in pharma and the value that it gives. The talk will discuss the considerations of data quality controls such as governance boards as well as the technology elements that enable the company to lift the data quality across the IT systems – and maintain this state.

It will highlight a couple of cases of data with data integrity, but low data quality and vice versa, in order to highlight the differences and how quality management activities best can handle them to support business value and regulatory compliance.

 

 

Nicoline Liu Poulsen+45 30778562nlpo@nnit.comMarketing Consultanthttps://www.linkedin.com/in/nicoline-liu-poulsen/Nicoline Liu Poulsen

 

 

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