Tracks included

  • 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

VENUE

Bethesda North Marriott Hotel and Conference Center 
5701 Marinelli Road
North Bethesda, MD 20852 
USA