Regulatory Submissions, Information, and Document Management Forum

8 - 10 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