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Overview

Short Courses: February 10
Forum: February 11-13


At the core of improving processes and building efficiencies is better organization and management of the data used in processes throughout the product lifecycle, an effort that can be complex and challenging under the best of circumstances.
DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum provides the elements needed to meet the challenges of optimizing the efficient use of regulatory information: the RIM principles, effective processes and tools, benefits to data applications across the product lifecycle, and examination of real-life results. 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

  • 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.

While we prepare the 2019 agenda, check out our 2018 Program to see what's in store!

Who should attend?

Professionals involved in:

  • Regulatory Affairs and Operations
  • Regulatory Information Management
  • Global Submission/Project Management
  • Medical, Technical, and Regulatory Writing
  • Data Management
  • Information Technology and Support
  • Document and eRecords Management
  • Essential Document Process and Business Systems
  • Regulatory Standards Implementation
  • Clinical Operations
  • Quality Assurance and Compliance
  • Contract Researchers and Service Support
  • Emerging Pharmaceutical/Biotech/Device
  • Vendor Relationship Management