ISO IDMP is the next wave in the pharmacovigilance legislation and a regulatory challenge. The time to get ready for it is now! Iperion can help you to solve this tough IT challenge.
Yes, we are aware that not all IDMP requirements are carved in stone yet. Thus, the need for a thorough but cautious approach is key. You can leverage on our expertise and applied business logics to achieve a sensible solution with enough flexibility to adjust to the final requirements of the EMA.
Our team of regulatory specialists support you by developing an IDMP readiness strategy. Our experience in regulatory operations, XEVMPD submissions combined with extensive production experience and our active approach in IDMP requirements review, ensures we are the right people to talk to. Currently we support a number of pharmaceutical companies in defining and preparing for the appropriate system landscape, required integrations and the organisational adjustments that are needed.
How to prepare for this IDMP compliance challenge?
Iperion can support you with one or more of the following activities on a consultancy basis or execute part of the IDMP readiness activities on a project basis.
- ISO IDMP awareness session
- ISO IDMP readiness assessment, including:
- Map IDMP requirements to your available data (leverage on existing XEVMPD data)
- Determine process coverage of ISO IDMP data
- Strategic and tactical advice on IDMP implementation plans
- Strategize on how and where the missing data needs to be collected (AS-IS versus TO-BE situation)
- Establish main areas of concern and additional areas of benefit
- Architect the overall IDMP landscape
- Support system/tool selection process
- Implement IDMP compliance
- Program and project initiation
- Data format alignment and missing data identification
- Develop/implement and integrate appropriate systems and tools
- Organizational embedding of systems and processes (incl. change management)
- Manual or automated data entry/data conversion
- Submission piloting
- Planning of next steps in RA / PV / QA and Manufacturing IT strategy