En acceptant tous les cookies, vous êtes assuré de profiter au mieux de notre site internet, d'avoir, entre autres, accès à des contenus personnalisés et aux liens vers les réseaux sociaux. En n'acceptant que les cookies obligatoires, vous n'utiliserez qu'un minimum de cookies lors de votre navigation, mais certaines parties du site pourraient ne pas s'afficher correctement. Pour en savoir plus, consultez notre Politique de confidentialité.
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