By Puni Rajah, Research Director at Governance Reviews
The ICSR legislation concerning improved pharmacovigilance reporting requires ISO IDMP standards to be used for the submis- sion of medicinal product information from 1 July 2016. We caught up with NNIT’s Rune Ringsholm Bergendorff to understand implementation implications of this new regulation.
Absolutely not. Everything you’ve sent in XEVMPD format will have to be updated. This is why we are advocating teams to assess the impact of ISO IDMP so they understand fully the task ahead. They need to identify data sources down to the system name, field name, data format, granularity and owner, based on the requirements of this standard. They will also need to capture all interviewed persons and roles/responsi- bilities for future reference – this will be the backbone of compliance.
Estimated July 2016 deadlines should be interpreted with extreme caution. It implies teams have prepared and submitted data in time for reviews and queries. This cycle usually takes about 5 months. To get to the stage of preparing data, updated data management systems need to be imple- mented and used for at least 10 months to allow for users to build their confidence. Prior to systems implementation, the really heavy work of preparing source systems needs to happen. We estimate this will typically take about 5 months, though some of this can be concurrent with system implementation efforts. Working back- wards, this means data management sys- tem upgrade budgets need to be signed off by the end of 2014.
Well, to determine required budget, teams will need to understand the scope of upgrade. The only way to do this is to evaluate the impact of ISO IDMP as part of a thorough assessment exercise. These assessments need to transform the data mapping into strategic input in terms of a GAP analysis and input for IT & system strategies. They have to include impact of controlled vocabularies and provide input for data architecture as well as corporate master data management (MDM) govern- ance. This will take at least 6 months. Allowing for a 3 month budget review cycle, you can see that the assessments need to have started in early April. Hence the urgency.
ISO IDMP involves a diverse set of stake- holders, from regulatory affairs (RA), clinical, manufacturing, labelling and R&D. So even though the project may be driven out of RA, the programme needs to ensure commitment across the board to deliver required data. This adds a unique dimen- sion to the complexity already inherent in the path ahead. Internal education before the summer of 2014 will be critical.
IDMP will depend on many data sources, and therefore IDMP compliance will be impacted by maintenance or upgrade of the underlying source systems. The status of IDMP as a governance checklist cannot be overlooked. Likewise with data modelling and MDM initiatives; IDMP and the impor- tance of the IDs (substance, pharmaceutical product, packaging, medicinal product created throughout the IDMP process) must be respected as a non-negotiable data management pillar. ISO IDMP is a much bigger deal than most of the industry understands today.