Whitepaper: Analysis of EMA's Product Management Services
A PharmaLex solution that exceeds your evolving needs.
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After much anticipation, EMA published the final Version 1 of the their IDMP Implementation Guide earlier this year. This Implementation Guide can be considered the handbook for the SPOR data base currently being built up as the European incarnation of the global IDMP standards. Even though being still incomplete – as it does exclude a number of topics and chapters indispensable for the SPOR data base to be operable – it can be considered a big step forward towards the arrival of IDMP datasets in pharmaceutical industry’s Regulatory and Pharmacovigilance daily business. Simultaneously, EMA, National Competent Authorities (NCAs) and Industry associations are working hard to define the particulars of the data maintenance requirements and to prepare the implementation of suitable submission pathways, integrating the provision of data into the established processes of submitting marketing authorization, variation and renewal applications and simultaneously allowing EMA and NCAs to perform data validation before a dataset is finally included into or updated in SPOR. The latter – integration of submission processes for data and documentation and inclusion of agencies into the validation process is also known as the SPOR Target Operating Model (TOM).