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IDMP – Identification of Medicinal Products
In January 2019, EMA has circulated the 1st draft of the EU Implementation Guide for ISO IDMP.
This version is currently under review by Industry, but provides the basis of the mandatory data elements for Iteration 1 of ISO IDMP. From this date onwards, Industry will have a 1 year implementation period for optional use of ISO IDMP, followed by a 1 year implementation period before ISO IDMP becomes mandatory.
With the current timelines, the mandatory date is expected by Q2/2022
Tasks that companies need to perform for ISO IDMP and Asphalion can support with:
- Data collection
- Data verification
- Data mapping and cleaning
- Tool review and selection (RFP, RFI)
- Tool and process adaptation and implementation
Given the above tasks that lie ahead for any pharmaceutical company, it is important to start as soon as possible to make an estimation of the effort in order to comply.
Asphalion has a dedicated team for ISO IDMP and is in direct contact with EMA and involved in the review of the EU Implementation Guide.
RIM – Regulatory Information Management
In order to comply with ISO IDMP, but even more importantly in order to optimize processes within a pharmaceutical company, a Regulatory Information Management (RIM) system is a vital element.
There are many different RIM solutions on the market and for a pharmaceutical company it is important to select a RIM solution that fits it’s needs. Not a single Pharma company is the same, with regards to the number of Marketing Authorisations, type of products, region of activities, manufacturer of finished product and/or active substance, etc.
As the implementation of a RIM solution is time consuming and involves a significant investment, it is important to make a proper selection of the final technical solution based on the requirements and needs.
Asphalion as a software independent company can support with an objective evaluation of the different RIM systems and needs of companies.
Selection of RIM:
• Set-up of User Requirements, Functional Specifications
• Report on the available RIM solutions in the market
• Preparation of Request for Information/Proposal for RIM implementation
• RIM system evaluation and final recommendation
• Consulting for business process translation into RIM
• Data Cleaning
• Data-migration and validation
• Project Management
Do you need support or more information about the services? Contact us!