eRA 2025 Pre-Conference Training
13 May | One Day 09:00 - 17:00
Subject to change
Join Us for an Engaging Pre-Conference Training at eRA 2025!
We are excited to welcome you once again to our highly interactive pre-conference training session ahead of the eRA 2025 conference. This isn’t a typical product training - this is a hands-on experience designed to bring our EXTEDOpulse end-to-end life sciences tools to life.
Explore how these solutions work together in a real-world context. Through an immersive, collaborative environment, you will actively engage with the tools, navigating a typical business scenario for life sciences professionals.
The training focuses on a standard eCTD (electronic Common Technical Document) workflow, guiding you through the collaborative processes of Regulatory Affairs Managers, Regulatory Operations, and Reviewers. Together, we will examine and address the challenges each role faces, fostering a shared understanding of the eCTD process.
Don't miss this opportunity to deepen your knowledge, improve your collaboration skills, and gain valuable insights.
Secure your spot today and get ready to learn, collaborate, and connect!
Introduction: "Simulation Game: Submission and Document Management Hubs"
Working on a Dossier in the Submission Management Hub
Submission Structures, Document Lifecycle, Lifecycle Filters & Views
Quickly assess Deficiencies and provide Annotations and Highlights
Networking Coffee Break
Follow-Up Submission Activities
Creating an Activity in the Registration Management Hub
Creating an Activity in the Registration Management Hub
Creating and updating Submission Documents in the Document Management Hub
Workflows and Tasks within the Document Management Hub
Workflows and Tasks within the Document Management Hub
Creating a Follow-Up Submission in the Submission Management Hub
Submission Lifecycle & M1 Modifications
Networking Lunch
Document Lifecycle (add/replace/append)
Adding Documents from the Document Management Hub, Check for New Version
Creating Hyperlinks
Exporting Submissions
Adding Documents from the Document Management Hub, Check for New Version
Creating Hyperlinks
Exporting Submissions
Business Case “Document Comparison”
Search & Favorites
Status of Annotations and Highlights
The “Regulatory Activities View” and “Authorised View”
Search & Favorites
Status of Annotations and Highlights
The “Regulatory Activities View” and “Authorised View”
Networking Coffee Break
Submission Validation
Uploading Submission to the DMS Submission Archive
Uploading Submission to the DMS Submission Archive
Open Stage for your Questions & Closing