By Marc Chaillou, International Markets Manager at Schlafender Hase
Looking at the life sciences technology market currently, pharma firms could be forgiven for assuming that ISO Identification of Medicinal Products (IDMP) compliance solutions are already available – even though the final requirements aren’t yet known. Not so, warns Schlafender Hase’s Marc Chaillou.
The fact that the European Medicines Agency (EMA) has against pushed back the deadline for ISO IDMP (Identification of Medicinal Products) compliance has not stopped the life sciences technology and services industry from promoting IDMP software and solutions today. This seems odd, when the finer details of the standards are not yet known. Seeing solutions apparently available on the market could encourage companies to invest inappropriately – putting the cart before the horse.
Certainly, life sciences organizations have their work cut out with IDMP – so there is every reason to try to get a head start. It will take a lot of time to align all the pieces. And unless companies can deliver the intended quality and reliability, the entire undertaking will have been a waste of everyone’s time. IDMP’s requirements are a great deal more comprehensive than previous attempts at electronic publishing standardisation (most recently XEVMPD) – driven by the need to ensure patient safety, as well as submissions management efficiency. But for IDMP to meet these loftier goals, data quality and reliability is paramount.
This is where companies should be focusing their efforts now – so that, once the final IDMP specs have been set down, they will only need to make some final, centralised tweaks to comply. It’s in firms’ own interests too that companies get their data up to scratch, offering them more visibility and control over their products and processes and the chance to make improvements.
But what’s involved?
The first task is for firms to review their various data assets, the different formats they are held in, and where these reside across the global organization. By creating a comprehensive inventory of files and file types, companies can start to understand the size and scope of the task that lies ahead.
This exercise may throw up a number of issues. For example, when there are multiple iterations of a document, which and where is the most up-to-date version? (This could be in Regulatory Affairs, Legal or Marketing.) If this is held in a document management system, which one? Very few organizations have a single comprehensive centralised system for holding content, so bringing content together or trying to compare one version with another is unlikely to be easy. If the company has been subject to mergers and acquisition activity, and/or has built up a range of different legacy infrastructures over the years, all of this will add to the data complexity. Across the wider ecosystem, contract manufacturers, CROs, local representative offices, translation companies and other service providers will also need to be surveyed for contributing product information.
Beyond core databases and document management systems, there are likely to be assets stored on people’s desktops, attached to emails, or kept in folders on servers without a common naming convention. If documents are PDFs, and do not contain selectable text, their content will be difficult to extract and re-use – machines will be unable to read it. Use of non-Unicode fonts – those that are displayed differently or incorrectly across software and operating systems – could also interfere with machine readability. Different languages, different spellings, corrupted content could all compromise consistency and accuracy as organizations work towards a definitive record of correct, current product information.
Files may have been broken up by Regulatory teams too – so that a master product information file running to 30-40 pages of detail on a drug may also exist as a series of separate Word files – e.g. containing the content for labelling, box content, patient literature – intended for the graphic design team. If these have been copied and pasted manually, and updated/corrected separately, the potential for variation will increase exponentially.
Given all of these risk parameters, it is surprising that so many life sciences companies continue to put off their IDMP preparations.
Companies will undoubtedly need help with all of this, but they need to be careful where they go for this assistance, especially when technology vendors are claiming to have IDMP compliance solutions available now.
Reap what you sow
Remember that how the prepared product information will be used is purely secondary. The priority must be to ensure that that data is correct, complete and usable – i.e. of value to the organization. Put garbage in and you’ll get garbage out. If companies are making the investment in information management, they may as well get the most they possibly can out of it.
Although IDMP solutions are little more than smoke and mirrors at this point, technology is the key to getting everything in order – and doing this efficiently. When it comes to selecting the definitive source documents, checking for updates, aligning languages, fonts and other intricacies, it is possible to very accurately compare files for the content they contain, even if they are in different formats. That’s as long as the chosen technology can ‘read’ content at a level which transcends font or file type. Being able to quickly compare the content of similar documents in large batches could save organizations vast amounts of time at this heavy-lifting stage of data preparation.
The final step, once EMA issues the final requirements, will be comparing pre-compliant content with them – ideally aided by the ability to filter by key words (controlled vocabularies) to ensure that quality checks are efficient and reliable. Assuming companies haven’t skimped on the data preparation, this final-stage task – definition refinement and submission – should be comparatively easy.
In the meantime, companies should keep an eye on EMA’s web site for the latest timelines (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp), and consider signing up to the IRISS Forum (https://iriss-forum.org/) – a not-for-profit body of pharma companies and technology vendors, and good source of knowledge and practical tips.
About the author
Marc Chaillou is International Markets Manager at Schlafender Hase, whose Text Verification Tool (TVT) is the most used software for automatically comparing artwork files with original Word sources, to improve proofreading accuracy and efficiency in highly regulated markets such as the pharmaceutical industry.