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Regulatory Submissions, Information, and Document Management Forum

08 February 2016

EDM, ERS, and RIM had combined for the 2016 Regulatory Submissions, Information, and Document Management Forum. This forum had covered topics in four tracks: Electronic Regulatory Submissions (ERS), Regulatory Information Management (RIM) Business, RIM Technology, and Electronic Document Management (EDM).

Presentations of Amplexor Life Sciences’ VP Strategy Romuald Braun:

Session 3 - Track 2 - ERS

Integral Submission Life Cycle – A Holistic Approach to Comprehensively Manage CMC Submission Documents and Processes Globally

Session 4 - Track 4 – RIM Technology

Structured Authoring - New Paradigm for Data Driven Authoring for Life Sciences?

Learning Objectives

  • At the conclusion of this forum, participants were able to:
  • Describe organizational processes and governance to ensure integrity, quality, and security of records
  • Discuss how to break down silos for end-to-end processing of regulatory information as it relates to EDM and ERS
  • Envision the scope and future of IDMP with respect to systems, process, standards and master data
  • Discuss organizational implications related to increasing electronic interactions with stakeholders
  • Explain ways to implement processes to improve reporting of regulatory expectations and communications
  • Interpret global health authority regulations and guidance’s for systems and processes
  • Describe how to map eTMF capabilities to support clinical site inspections
  • Identify techniques to create efficiencies in the overall end to end process of document and submission management

Photos

Busy @ Amplexor Life Sciences Booth