Regulatory Submissions, Information and Document Management Forum

At the Regulatory Submissions, Information, and Document Management Forum, DIA will present four tracks and daily health authority plenary sessions to provide a comprehensive view of content and regulatory information management and submissions. All tracks are supported with daily plenary sessions providing regulatory intelligence updates by health authority representatives from FDA, Health Canada, and other regions of interest.

This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business- and technology-focused attendees. Tracks include:

• 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.