Testing and Implementing a Web-Based, Country Regulatory Information Management System
By Elizabeth Rehfeld -
Published 13 January 2017
This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform.
Categories: Features, Project management, Regulatory intelligence
Tags: Information management, Regulatory information management system
The Expanding Role of Regulatory Operations: How Technology Advances Have Equipped Operations Teams to Play a New Strategic Role
By Craig Gassman, MS -
Published 28 July 2016
This article discusses the expanding function regulatory operations plays within organizations and how their broader responsibilities as process engineers, RIM systems experts and business analysts will play an increasing role in the organization's success.
Categories: Features, Business Skills, Submission and registration
Tags: Regulatory Information Management, RIM, Regulatory Operations
Transformation Underway in how Regulatory Information is Globally Managed
By Steve Gens, Greg Brolund, Sarah Powell -
Published 27 July 2016
This article discusses a new World Class Regulatory Information Management (WCRIM) standard and current industry status.
Tags: Regulatory information management
ISO IDMP: Another Compliance Project or a new way of Conducting Business?
By Rune Bergendorff -
Published 19 April 2016
This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently.
Categories: Features, Europe, EC, EMA, Drugs, Labeling, Packaging
Tags: IDMP, ISO, Identification of Medicinal Products, Regulatory Information Management