In June, EMA released the draft of the 2nd version of the ‘IDMP/SPOR PMS Implementation Guide’ which is now in the consultation phase.
This new release contains an updated chapter 2 (Medicinal Product Information) and a first version of chapter 3 for the process on how product data should be submitted as part of the Target Operating Model (TOM).
Once the consultation is finished it is expected that the final version of the Implementation Guide will be published by Q4/2020. This publication should be the start of the 24-month period before IDMP becomes mandatory for the industry.
The IDMP Readiness Questionnaire
With the mandatory use of PMS approaching it is time to take the necessary steps to smoothen the transition towards IDMP implementation. But how IDMP-ready are you? To find out, Iperion Life Sciences Consultancy has designed a two-part tool: the IDMP Readiness Questionnaire.
The initial part assesses one’s current Product Information Management maturity level by approaching it from the four different perspectives: Process, Organization, Technology and Information. The second part identifies the organization’s activities in relation to EMA’s IDMP implementation via SPOR.
After submission Iperion will provide a personal report including a presentation on the submitted results by an IDMP specialist on the next steps and topics that require attention from an IDMP readiness point of view. These reports will be provided without any obligation.