Regulatory Operations - The Digital Imperative - Strategies for a data-driven regulatory landscape

- Data quality, interoperability & data governance in Regulatory Affairs - AI, automation & digital transformation in Regulatory Operations - IDMP, SPOR & the evolution of data sources - eCTD 4.0 & ePI - the new submission and product information landscape - Future trends & strategic positioning of Regulatory OperationsThis seminar covers the key drivers of digital transformation in Regulatory Operations - from data quality and AI-driven automation to IDMP, eCTD 4.0, and ePI. Across two half-day sessions, you will gain practical strategies and discuss real-world use cases with experienced practitioners.LernzieleThis intensive seminar spanning two half-day sessions provides a comprehensive overview of the digital transformation in Regulatory Operations. From data quality and AI-driven automation to IDMP implementation and eCTD 4.0, all key aspects of a modern, data-driven regulatory landscape will be addressed. - You will learn how to ensure data quality as the foundation for RIM performance and AI-readiness, and how to leverage automation and cloud-based platforms to streamline your regulatory workflows. You will also gain in-depth knowledge of IDMP/SPOR requirements, the transition from XEVMPD, and the upcoming eCTD 4.0 and ePI frameworks.- Through real-world use cases and interactive group discussions, you will be equipped with practical strategies to position Regulatory Operations as a strategic data hub within your organisation.ZielgruppenThis seminar is aimed at professionals working in the field of regulatory affairs and regulatory operations, as well as adjacent roles involved in regulatory systems and processes. It is also relevant for professionals in quality assurance, pharmacovigilance, and data management who work at the interface of regulatory submissions and digital transformation.- Participants are expected to have a solid understanding of EU regulatory procedures.