In July 2022, the Regulatory Information Management (RIM) Working Group of DIA’s Regulatory Affairs Community, including V. “Bala” Balasubramanian, Orion’s Global Head, Healthcare & Life Sciences, issued a white paper that provides insights on how The RIM Reference Model benefits the companies and RIM system providers that adopt it.
Read the extract of the white paper below.
Regulatory affairs is evolving from a document-centric to a data-centric practice. Historically, companies have tracked and managed registrations, submissions, health authority interactions, release requirements, variation impact assessments, and other key regulatory activities through spreadsheets, homegrown systems, or data hidden in documents. There is increasing emphasis on global marketing of products; the need to comply with changing global regulatory requirements increases volume and complexity of information. Managing this new reality in traditional ways is not sustainable.
Regulatory Information Management (RIM) has emerged as a fast-growing area to streamline and enhance the regulatory value chain with a set of capabilities built on process, data, technology, and organizational components. More recently, RIM data and system capabilities have evolved beyond merely supporting regulatory goals and objectives to providing integrated data flows with other functions (e.g., clinical, manufacturing, safety) across the value chain.
Accompanying this evolution has been a widely divergent understanding of RIM’s scope, nomenclature, terminology, processes, data requirements, etc., which has unfortunately resulted in incongruent processes, data structures, and terminology, thereby increasing complexity in building and operating regulatory information management capabilities… Read more.
Explore Orion’s Healthcare and Life Sciences services.
Learn more about Orion Regulatory Affairs Lifecycle Management Platform (ReALM®).
Join us for our webinar on How Emerging Life Sciences Companies are Transforming Product Registrations with Technology.
