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We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.
Article 57 xEVMPD to IDMP/SPOR – Automated Consistency Check
As stated in our previous blog, EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it clear that data quality [in PMS] is dependent on xEVMPD. PMS, the Product Management Service out of the EMA SPOR project builds on the data foundations of the Referential …
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Article 57 xEVMPD to IDMP/SPOR: PMS Data Migration
EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it more than clear: data quality [in PMS] is dependent on xEVMPD. In our previous blog on PMS Data Migration we highlighted some of the challenges faced by Marketing Authorisation Holders (MAHs) already and these challenges …
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Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?
The situation All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from …
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