DIA - Regulatory Submissions, Information, and Document Management (RSIDM) Forum
11 February 2019
RIM Business track addresses processes for obtaining and managing regulatory information, organizational impact, and key issues shaping the global regulatory and business environments.
RIM Technology track focuses on standards related to submission of regulatory information, tools to effectively manage the information, implementation experiences and results, and implications for refinement.
Electronic Regulatory Submissions (ERS) track explores the submission process, regulatory requirements and new developments, best practices in regulatory submissions and industry adoption techniques.
Electronic Document Management (EDM) track examines the processes, systems, and best practices for content management across the product lifecycle, including alignment with the RIM system for optimal use of regulatory information.
Learning objectives of this forum
Explain the regulatory electronic submission process from the completion of its upload to the Electronic System *Gateway (ESG) through the time the submission is made available to the review team
Discuss the agency target time frames for the 1) expected submission upload duration(s) and 2) timeframe between key milestones and notifications
Describe the current required data standards for regulatory submissions and the status of ongoing data standards initiatives
Describe organizational processes and governance to ensure integrity, quality, and security of regulatory information (data, documents, records)
Examine the scope and assess the future of data standards, including IDMP, with respect to systems, processes, and master data
Discuss ways data can be harmonized, integrated, and viewed to provide an end-to-end view of the regulatory information value chain
Discuss organizational implications related to increasing electronic interactions with stakeholders and health authorities
Explain ways to improve processes and communication of regulatory activities including communications, end-to-end processes, and integration of systems for document, submission, and records management
Interpret global health authority regulations and guidance's for systems and business processes
Identify ways in which the integration of data, documents, and knowledge can be leveraged to develop insights and enable better business decisions
Identify changes in submission-related regulations impacting RIM business processes
Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road North Bethesda, MD 20852 USA
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