The Samarind approach to IDMP
The MA Holder’s dilemma
Holders of European marketing authorisations (MAs) are showing great interest in the subject of IDMP, keen to avoid the xEVMPD debacle of 2012, where many organisations found themselves with insufficient time to implement a suitable system with which to submit their data in time for the 2nd July deadline.
The ISO IDMP standards have been available for several years and are being studied by a wide range of stakeholders, from EMA and industry associations to software vendors and consultants, as well as MA holders themselves. The depth and breadth of data that ‘could’ be required for each medicinal product is quickly being appreciated and requirements analysis projects are already underway in most organisations. Before long, most of these will at least know where all their IDMP data resides at the moment.
BUT – what will they do with this information? The most frustrating thing for everyone concerned is not knowing how much of each of the standards will be implemented and when. Europe will be the first to implement IDMP, with the EMA deciding on a phased approach based on the four domains of master data in the pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.
Although the EMA is implementing the standards in a phased programme, there is still much to do to evaluate and implement a suitable solution by July 2019.
The right approach
Understanding the IDMP standards and knowing where your data is currently is, of course, absolutely the correct first step. Determining whether it contains all the information that might be required and at the right granularity is also part of the evaluation process that can be carried out now. We are already offering guidance and consultancy services in this area and whilst the scope of IDMP is indeed enormous, once the unknown becomes known it becomes less frightening.
Once you know where your data is, the next steps are to find software vendors offering an IDMP solution and start to evaluate both the vendors themselves, their expertise in IDMP and the solutions they provide. Here are some questions you might like to ask.
- Do you want, and can the vendor provide, a full RIM solution (including tracking and lifecycle management) or just an IDMP data collection tool? In 2012 some organisations chose just an xEVMPD data tool and consequently have to look for another vendor for IDMP and have missed out on all the other benefits a fully integrated system can provide.
- Is the vendor committed to supporting IDMP in its fullest possible implementation or are they looking to make a fast buck from the scramble to implement a minimal solution by July 2019? Unless you really are out of time and/or budget, taking a forward-looking approach and choosing a system that will be able to support you for many years into the future is surely the best solution.
- Are you aiming for one system that can contain pretty much everything, either directly or by interfacing automatically with other systems, or are you happy to have multiple separate systems and put up with having to enter things multiple times? Sometimes this comes down to available budget, but it can also be influenced by general company strategy and how entrenched existing systems are.
- Will the vendor be able to meet the EMA deadline? Vendors with an agile development team, well-defined processes and a track record will fare much better than larger or less experienced companies.
These are, of course, in the addition to the standard supplier selection questions and your own decisions regarding budget, project team resources etc.
The Samarind concept
The Samarind RMS concept is that we have a single, integrated, properly-structured database that provides the ‘single place of truth’ for your medicinal product information. Each piece of data is stored only once in the correct place in the structure and then utilised wherever it’s needed; there is no unnecessary duplication of data and data consistency is assured. When any type of submission is required, whether it be the meta data for an eCTD, active ingredient information for an ICSR or any of the data required for xEVMPD, the data is simply pulled through from where it lives and gathered together in the necessary format.
With IDMP it will be the same; we just gather the data together from where it logically lives, turn it into HL7 format and output the file for submission. As with xEVMPD, we’ll enforce the business rules as we go along and provide an IDMP summary form so that you can check that everything is complete. If you’re not familiar with our solution please get in touch and let us show it to you.
A full RIM solution
As a RIM solution with extensive coverage of the whole medicinal product lifecycle, Samarind RMS already has the advantage of including much of the information required for ISO IDMP. Coverage of the standards is already extensive:-
- Samarind RMS already contains around 70% of the information defined by ISO 11615 (medicinal product) and ISO 11616 (pharmaceutical product), which is reducing our development time.
- Almost all of ISO 11239 (dosage forms, units of presentation, admin routes and packaging) and ISO 11240 (units of measurement) are already included, so database changes are minimal.
- We are currently enhancing our data structures to include the remaining ISO IDMP data elements, as required, well in advance of any deadlines.
We are also watching closely the developments around ISO 11238 (substances) and are looking forward to integrating with GInAS, the US-led open development of a global substance registration tool.
An expert team
Our technical team is fully on board with the ISO IDMP subject, having been working with the ISO IDMP standards since they were released in 2012. We are members of the (European-focused) IRISS IDMP group and the USA’s IDMP External Working Group (IDEX); we attend all related meetings and conferences and have regular contact with other industry experts such as Andrew Marr and Vada Perkins. We contribute enthusiastically to meetings and requests for comment and share this information with our customers.
Samarind’s track record
Because of the underlying architectural design of Samarind RMS and the fact that we already have most of the IDMP data elements already in place, we expect to be first to market with a fully compliant ISO IDMP solution for the EU very soon after the EMA publishes its IDMP implementation guide.
In 2012 Samarind was first to market with a fully working xEVMPD solution, enabling our existing customers to submit their data to the EMA by the 2nd July deadline. In 2014 our release with full support for the new schema and all the maintenance processes was released at the end of June, just a few weeks after the EMA’s test system was available.
We have further demonstrated our expertise in this area with our xEVPRM Loader Tool, which imports xEVMPD data into Samarind RMS, and our XEVPRM Comparison Tool, which is becoming an essential tool for MA Holders wishing to review the changes that EMA has made to their data as part of the QC exercise.
For more information or to see Samarind RMS in action, please contact us.