Skip to main content
RAPS Euro Convergence 2024 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Ticketed Event
Ticketed Event
Sponsored Presentation
Sponsored Presentation
Learning Level: Foundational
Learning Level: Foundational
New Exhibitor
New Exhibitor
Networking Event
Networking Event
Enterprise Network Member
Enterprise Network Member
Learning Level: Expert
Learning Level: Expert
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Intermediate
Learning Level: Intermediate
Back
Download Certificate ViewAttendees 7

Pharmaceuticals

Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions

Tuesday, May 7, 2024
09:50 – 10:50 CEST
Location: B 05 + B 06
Learning Level: Intermediate
Description: In this session, we will explore and discuss the latest advancements and trends in the electronic Common Technical Document, with particular focus on cloud integration, data standards, and publishing strategies. We will look at how regulatory frameworks are evolving and influencing eCTD submissions as well as what this can mean for stakeholders. Insights on the global implications of changes in eCTD, including how different regions are adapting to the advancement of eCTD version 4.0 and implementation of the Investigational Medicinal Product Dossier, will be shared along with expert opinions and strategies for navigating key challenges and solutions. Both current trends and the future of eCTD applications will be examined.

Learning Objectives:

  • Panelists provide expert opinions on the latest advancements and trends in eCTD, particularly focusing on cloud integration, data standards, and publishing strategies.
  • Highlight how evolving regulatory frameworks are influencing eCTD submissions and what this means for stakeholders.
  • Share insights on global implications of changes in eCTD (e.g. v4.0), including how different regions are adapting to these advancements.
  • Identify & discuss key challenges in the implementation and integration of eCTD in the cloud, and to explore potential solutions and best practices.
  • Forecast directions and potential innovations in eCTD and regulatory submissions, based on current trends and expert opinions.
  • Recommend strategies for navigating the varying requirements of different health authorities for eCTD submissions.