By Scott Mitreuter, Product Manager, Sparta Systems
Beginning in early 2017, life sciences organizations that intend to manufacture and/or market medicinal products within the European Union will be required to comply with the Identification of Medicinal Products (IDMP) regulations, a global framework for identifying medicinal products, set forth by the European Medicines Agency (EMA).
Intended to create the utmost transparency between regulators, manufacturers, suppliers and distributors, IDMP will ultimately ensure public safety by enabling greater operational efficiencies and reducing errors and inconsistencies, as well as reducing the risk of negative audit results. Unique IDs are introduced at every stage of the supply chain for full traceability.
Although the requirements are not fully established, many companies currently do not see IDMP implementation as a major business challenge that they need to start dealing with. This, however, could turn out to be a very big mistake.
The vast amount of data disclosure required for IDMP compliance poses a significant challenge to organizations, as all too often product information is scattered across a variety of systems and business functions. No single entity maintains ownership of the necessary data.
How do you ensure full control of your product releases, labels and IDMP data sets on a global scale? To gain a better understanding ahead of the regulation being fully established, here are three of the most important questions that should be considered, along with insights to guide the process.
What data will be gathered?
Data is broken up between Medicinal Products, Clinical Particulars, Pharma Particulars, Ingredients/Substances, Packaging and Manufacturing. There are approximately 250 data fields collected within those buckets.
The amount of data required for IDMP quickly adds up when you consider its entire complex structure. This information describes what a product is, where it is authorized, how it looks and where its ingredients and parts come from— all used to answer questions for patients, such as: “Where did you package my drug?” and “Which formula was used to produce this drug?” One active ingredient that produces three pharmaceutical products, distributed across 50 markets with four different package sizes, may total more than 600 IDMP entries.
Who from within an organization should be involved in the process?
There must be an extremely high level of collaboration between departments to assure compliance. Senior-level stakeholders from all departments that touch the data, including C-suite executives, should have a hand in the process. Alignment and planning activities should be organized and implemented to include all relevant groups within the business so that each team member collaborates effectively while understanding the end goal.
How should an organization find, collect and process this data?
Organizations should go through an initial discovery phase in order to determine where its data resides and if it needs to be cleansed, which is typically a consulting effort. Once these data sources are determined, the information will need to be collected and provided to a central IDMP system for processing.
This may all sound quite daunting, but it is absolutely critical that life sciences organizations fully understand how to collect and process this unstructured data in a streamlined manner ahead of the impending regulations. If these organizations are not prepared for the eventual submissions and application deployment, they may find themselves in an unfavorable position once the standards are approved.
About The Author:
Scott Mitreuter is a product management manager at Sparta Systems. He has 15 years’ experience in the Life Sciences Software Industry include various roles in product, services and system implementation for Life Science customers. He holds a B.S. in Computer Science from Villanova University with a minor in Cognitive Science.