As drug development and market approval grow more connected and complex, effective regulatory information management (RIM) is more essential than ever. In DIA‘s new podcast, SVP – Life Sciences, V. “Bala” Balasubramanian and Managing Director of Regulatory Compliance & Quality at Grant Thornton LLP, Patterson Shaffer discuss the impact of data on clinical research and product development. Both Bala and Patterson serve in the working group for developing the Regulatory Information Management (RIM) reference model that was recently discussed at a DIA RSIDM workshop in February 2020.
When asked about how to define RIM, Bala explains that it comprises data, metadata, information and documents that are either produced or consumed by Regulatory for other functional areas. Bala also speaks about why regulatory data should be treated as a corporate asset.