The suite of ISO IDMP data standards has the potential to support a broad spectrum of transformational new healthcare and regulatory applications. Yet articulating the benefits of IDMP adoption to a CEO or CIO remains a challenge for project proposers, who must confront the common perception that this is merely another compliance cost.
Iperion Life Sciences Consultancy provides a range of IT services to help companies transition towards process transformation and service innovation, underpinned by comprehensive, high-quality, standards-based data. Our services will help to optimize internal processes and sharing of information between different technology solutions and departments, in turn supporting new service potential.
We believe that, approached with the right vision, the benefits of IDMP implementation need not be restricted to the organization itself. Rather, embracing the standards and the ethos behind them could -and should – contribute to a greater public health system and new and better experiences for consumers and patients.
Honing your aim, shaping your journey
In this blog series, we will explore the various potential use cases as a basis for designing and optimizing companies’ respective IDMP deployments. Our goal is to raise awareness about the wider potential: how IDMP could be applied to transform both internal regulatory and external healthcare business processes – so that organizations appreciate more fully the potential return on investment.
These articles will explore and expand upon the stated use cases described in the IDMP standards, which supports a variety of interactions between global regulatory authorities, bio/pharmaceutical industry, clinical research organizations, healthcare and other stakeholders. Crucially we will also dig deeper into the data requirements that drive and support information exchange, by assessing the data requirements for specific use cases such as Pharmacovigilance; Regulatory Affairs / TOM; CMC; Labelling / Artwork; Supply Chain; and Quality.
Each article in the series will focus on the information (data elements or data domains) needed to create specific datasets or data exchange files, and how they are supported in the IDMP standards. For example, the ePrescription use case will focus on the data elements described in EU legislation Article 14 of Directive 2011/24/EU. The IDMP standards build upon each other and, once a data element or information domain is addressed within an implementation, the data can be repurposed for a variety of uses. So, for instance, information about a manufacturing facility (an IDMP data element) could be used to trace and track a product’s supply chain for custody status or possible source contamination.
We invite you to join us on this journey to explore IDMP’s various potential use cases. We welcome your feedback, too. If you are interested in partnering with us to further explore and document a specific use case, please drop us a line at email@example.com. We’re keenly promoting the bigger picture for IDMP, and would be delighted to hear from you.
My name is Lise Stevens. I am currently serving as Associate Director for regulatory information management and pharmacovigilance at Iperion in the US. My personal philosophy is deeply rooted in the belief that good health and overall well-being is a basic human right and collectively healthcare providers, regulators, bio/pharmaceutical companies and health IT vendors equally share in the responsibility to protect and promote public health – especially in underserved or under-represented populations. In addition to this, am I a Certified Ayurvedic Wellness Counselor.