Amplexor’s recent BE THE EXPERT industry forum in June was invigorating for everyone that attended. This was down to not only the caliber of people that attended and the inspiring visions they painted, but also the practical advice and examples of progress that brought those aspirations to life.
Instead of being merely reminded of the need to transform the way we manage and use product information, regulatory professionals were guided through the recommended next steps and talked through the role that technology can play.
In my session, I explored how companies can embrace evolving regulatory standards to define a practical target operating model for managing their product data so that what is submitted to regulators is an accurate reflection of the current truth. While much of the advice around ISO IDMP preparations concerns how different categories of data must be categorized and formatted, the bigger picture surrounds how firms can get that data into the hands of those who need it – and quickly. I don’t just mean the EMA and other international regulatory bodies, which before long will insist on accurate and complete data filings alongside traditional dossiers. I’m also referring to patients of medical products, and those prescribing or selling them.
It was good to see patient-centricity made a focus in several of the presentations at BE THE EXPERT 2019, because companies get so caught up in their regulatory obligations that they can lose sight of why we’re doing all this. Once product records are brought under control, and consolidated in a robust, credible and definitive living record (a single, up-to-date version of the product truth), there are plenty of other keen consumers of that information besides the industry watchdogs. Certainly, in the digital age, it shouldn’t be taking months or years for the latest safety advice to filter through to patients, simply because patient information leaflets haven’t been updated. In future, we can expect to see QR codes being used as standard to provide links to the latest instructions for use online: access to the latest data will be much more immediate and convenient.
All of which comes back to the need for companies to have an accurate master data source, along with visibility of where this data is re-used and a way of managing interoperability between the central master and wherever information has been reproduced. Even keeping submitted regulatory dossiers and electronic data equivalents in sync will require appropriate controls, because information may continue to be updated after original documentation has been put together.
It is undoubtedly unfortunate that the timelines around IDMP have been subject to delays, slowing down preparation of a definitive data truth about products that clinicians, pharmacies, patients and other stakeholders could benefit from today. But this needn’t stymie all progress. For just a few hundred dollars, any company today can buy the ISO IDMP specifications from their local standards organization and begin working toward a target operating model for wider data exchange.
It’s worth remembering that 60 countries participated actively in proposing and setting these new ISO standards, and 160 countries have pledged to recognize and enforce them. That’s a pretty strong endorsement to justify preparing and managing electronic product data in support of wider public access. Committing to this is an important step toward the democratization of healthcare and medicine data which Ruud Veltenaar spoke about in his keynote address at the conference.
If society’s growing expectations are not enough of a driver for change (and they should be), consider this. A technological giant like Amazon may yet disrupt the life sciences industry, using as its leverage its superior grasp on information management to create new value around medicinal products for consumers. It is not beyond the bounds of credibility to imagine that if Amazon wanted to buy the intellectual property for a drug compound, along with the other operational elements to running a pharma business, it could establish a healthcare organization with relative ease. In the pharma industry, product information is vastly underestimated as a business asset, and if firms don’t want to leave themselves exposed to huge risk by failing to gain control of this, they must act now.
Frits Stulp is the Managing Director of Iperion Life Sciences Consultancy. He has been the Program Manager of the first completed IDMP implementation program, and also a member of the EMA ISO IDMP Task Force.
Agnes Cwienczek 2min read 02/08/19