Update eCTD 4.0 - Requirements, Timelines and Transition Strategies

- Regulatory updates and current timelines - Key technical changes compared to v3.2.2: submission grouping, forward compatibility and dossier migration - Best practices for dossier lifecycle management under eCTD 4.0 - Transition preparation: internal readiness & learnings from the EMA pilot - Practical live demo & discussionGet up to speed on eCTD 4.0: EU timelines, technical changes, transition requirements and pilot learnings - all in one focused half-day session including a live demo.LernzieleThis half-day seminar provides a focused and practical update on eCTD 4.0 - from regulatory timelines and technical changes to real-world transition experience. - You will gain a thorough understanding of the key differences between eCTD v3.2.2 and v4, including submission grouping and forward compatibility, and learn how to manage dossier lifecycles effectively under the new standard. - Drawing on real-world experiences from the EMA pilot and a live demonstration, you will leave with concrete guidance on what your organisation needs to prepare before making the switch to eCTD 4.0.ZielgruppenThis seminar is aimed at regulatory affairs professionals and submission managers responsible for eCTD dossier preparation and lifecycle management. It is also relevant for regulatory operations teams and anyone involved in planning or executing the transition to eCTD 4.0.- Participants are expected to have a solid understanding of EU regulatory procedures.