SAS® Analytics supports global standard regulations for pharma
Effort strengthens worldwide regulatory drug development process and improves patient safety
The life sciences industry is one of the world’s most regulated. Pharmaceutical organizations must navigate and comply with complex global, regional and industry-specific regulations, standards and codes that span a drug or device’s developmental and commercial life cycle. To aid organizations in meeting these regulatory requirements, leading analytics software and solutions developer SAS has developed a single platform to support companies seeking to comply with data standardization activities such as the Identification of Medicinal Products (IDMP).
IDMP is a global regulatory standardization framework developed in response to a worldwide demand for internationally consistent specifications for medicinal products and substances. Ensuring all stakeholders use the same messaging format and vocabulary secures greater interoperability as well as pharmacovigilance oversight.
“SAS brings a deep understanding of regulations and industry experience to the development of an IDMP platform,” said Mark Lambrecht, Director of the Global Health and Life Sciences Practice at SAS. “All regulatory agencies will have different timelines, and this offering will help our customers comply with data standardization and product safety regulations globally. This is an excellent example of the use of advanced data management and analytics to improve production and safety of pharmaceuticals and medical devices.”
Anticipated to be among the most influential standards created for the global life sciences industry, every pharmaceutical, biotechnology or medical technology company that sells or sponsors products in the European Economic Area will be affected. It is expected that other regulatory agencies such as the US Food & Drug Administration and the Pharmaceuticals and Medical Devices Agency in Japan will also adopt these standards into regional legislation.
For many pharmaceutical companies, information to comply with the IDMP requirements is located in disparate systems or documents exhibiting varying degrees of quality. The challenge for these organizations is to integrate, standardize and govern unstructured and structured IDMP source data found across the enterprise. Once identified and standardized, messaging capabilities must secure bidirectional transfer of the IDMP messages to regional regulatory bodies. Accomplishing this requires extensive experience within the life sciences domain, integration and data standardization — all core competencies of SAS.
In addition to IDMP compliance, the platform delivers a foundation to support other regulatory requirements. This includes the Falsified Medicines Directive and the General Data Protection Regulation that takes effect in May 2018. The platform offered by SAS exhibits adequate flexibility to help accommodate regional regulatory requirements while utilizing advanced analytics to continuously facilitate data driven benefits.
Access the SAS IDMP website to learn more about the challenges pharma face in complying with IDMP and SAS’ solution.
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