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By clicking SUBSCRIBE, you are agreeing to our Privacy Policy.This Whitepaper is part of a broader initiative of the Regulatory Information Management (RIM) Working Group within DIA’s Regulatory Affairs Community. The Working Group has identified significant potential value from development of a RIM Reference Model, a conceptual framework for RIM systems and processes. The Reference Model is intended to aid organizations in structuring the complex organizational, data, process, information, and workflow issues as they implement or upgrade their RIM systems. The Whitepaper is an expansion of an earlier RIM consensus paper. Version 2.0 covers a broad range of regulatory capabilities, including but not limited to regulatory intelligence, planning and tracking, labelling, correspondence and commitment management, change control, regulatory analytics and use of AI and machine learning technologies. The paper includes definitions, trends and best practices reflecting the experience of the authors and editorial team who represent well over 100 years of industry experience.
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DIA Community for Document and Records Management developed an initiative aimed at developing a taxonomy/metadata reference model that can ultimately be shared by biopharmaceutical organizations as a common starting point for building sustainable, shareable EDM repositories.
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DIA Community for Document and Records Management has defined the critical requirements for destruction of paper records for better content management.
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Represents the combined work of DIA volunteers in the Document and Records Management community and provides a model of accepted practices across the industry for the organization (taxonomy) and metadata properties of GMP Quality Systems documentation. Can be used by any biopharmaceutical company as a common starting point for building sustainable, shareable repositories for the management of GMP Quality Systems documentation.
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The TMF Reference Model defines standard contents, structure, terminology and metadata for the Trial Master File, essential documents which allow verification of the conduct of a clinical trial and the quality of the data generated.
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In 2006, DIA was among the first organizations to recognize the importance of patient involvement in drug development and launched its first Patient Fellowship Program. Since then, the role patients can play in therapeutic product R&D has exploded. DIA continues to lead the way, providing input and insights into the evolution of therapeutic product development, and driving towards improved health and well-being throughout the world. DIA believes patients should be at the epicenter of the drug development life cycle, and for more than 15 years has pioneered efforts to advocate for the patient voice and discuss future patient engagement efforts across the health care continuum.
DIA-CTTI DIA-EUPATI DIA-PCORI DIA-Tufts
Engaging patient stakeholders in benefit-risk decision making throughout the medical product life cycle is key to meeting patient needs. This visual model, created by participants of a 2015 DIA conference on this topic and partially funded by an Engagement Award from the Patient-Centered Outcomes Research Institute (PCORI), depicts how we are engaging patients in benefit-risk decision making and where stakeholder efforts can improve patient outcomes.
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