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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