An Overview of EU SPOR Project

doi:10.19803/j.1672-8629.2019.12.03

Abstract

Abstract: Objective To study the details of implementation of EMA SPOR Program so as to offer ideas and referential methodologies for IDMP-related practices in China. Methods IDMP standards as well as the EMA SPOR Program were studied by analyzing the ways in which a drug dictionary was compiled by the EU that complies with the IDMP standards. A comparison was also made with the actual situation in China. Results IDMP standards involve an enormous data structure, and the SPOR Program effectively divides the whole process into reasonable and executable phases, allowing smooth communication and collaboration between stakeholders across phases. Conclusion The implementation of the SPOR Program will be of multiple benefits: increased data quality, more efficient regulatory action and decision-making, reduced data silos and operational savings and efficiencies due to re-usage of data.

Key words: SPOR, drug dictionary, IDMP

CLC Number:

R951

HOU Yongfang, LIU Hongliang, LI Xinling, LIU Ling. An Overview of EU SPOR Project[J]. Chinese Journal of Pharmacovigilance, 2019, 16(12): 716-721.

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https://zgywjj.magtechjournal.com/EN/Y2019/V16/I12/716

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