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EURS - The EXTEDO Universal Reviewing System


Description
The reviewing of electronic submissions upon receipt is a critical process for regulatory authorities.
EXTEDO EURS provides you with tools for the validation, acceptance, import, review and maintenance of eCTD, NeeS-based and non-eCTD submissions, giving you complete confidence that they conform to your official standard.

Validating large numbers of submissions can quickly become a bottleneck, requiring a significant investment in both time and resources. EXTEDO EURS is designed to simplify the validation and review of regulated electronic submissions with authorities. With validation, review, approval, maintenance and importing tools, EURS is the solution of choice for many regulatory agencies around the world.

This course is targeted to users of EURS in pharma authorities and in the pharma industry.

As one of the NCA´s leading validation and reviewing solutions, numerous regulatory authorities use EURS to support their internal review processes. With periodic modifications to the ICH eCTD and Module 1 specifications, as well as ICH-developments and other changes introduced, EURS is continually updated to ensure that it remains at the cutting edge.

EURS is powerful, yet simple to deploy within your agency. Depending on your system specifications, EURS can be installed and validated within a matter of days. Its user-friendly and intuitive interface is equipped with an integrated, context-sensitive online help that ensures ease of adoption amongst your users and minimizes the need for expensive structured training sessions. Supporting distributed workforces with many hundreds of users, EURS is an extremely scalable solution.

(Last Revision Q1/2021)
Content
  • Introduction
  • Introduction
  • Session 1: Starting EURS and work in the User Interface
  • Starting EURS
  • Working in the EURS User Interface
  • Exercises to EURS Session 1
  • Session 2: How do you recognize an eCTD
  • How to recognize an eCTD
  • The purpose of the MD5 checksum
  • Exercises to EURS Session 2
  • Session 3: Import an EU submission
  • Importing a Submission
  • Import an incompliant Submission
  • Tools after Import
  • Exercises to EURS Session 3
  • Session 4: The Module 1
  • The EU Module 1
  • Basic Features of the Document Viewer
  • The South African Module 1
  • Module 1 for Other Regions: The Gulf Cooperation Council GCC and Jordan
  • Exercises to EURS Session 4
  • Session 5: Specific Sections and Node Extensions
  • Specific Sections and Node Extensions: CMC Data
  • Non-clinical and clinical Studies
  • Exercises to EURS Session 5
  • Session 6: Collecting Documents - Full Text Search and Favourites
  • Collecting Documents: Full Text Search and Favourites
  • The Document Explorer
  • Exercises to EURS Session 6
  • Session 7: Reviewing Documents - Annotations, Highlights and the Scratch Book
  • Annotations, Highlights, ToC Annotations and the Scratch Book
  • Creating Reviewer Hyperlinks
  • Exercises to EURS Session 7
  • Section 8: Import Follow-Up Sequences
  • Import Sequence 0001 and other Follow Up Submissions
  • Session 9: Document Lifecycle, comparing Document Versions
  • Color Codes, Filters and Views
  • Document Lifecycle
  • Comparing Documents and Document Versions
  • Annotations in Follow-Up Sequences
  • eCTD Dossier Lifecycle: some examples of follow-up sequences in EU dossiers
  • Exercises to EURS Session 9
  • Section 10: Additional Settings and Tools
  • Additional Settings in Project Explorer and Submission Explorer
  • Session 11: Do you need external Assistance?
  • Do you need External Assistance?
  • Create an assessment report from the scratch book
  • Exercises to EURS Session 11
  • Section 12: EURS features for Power Users
  • Dossier Groups
  • EURS Customized Attributes
  • Remove Submissions and Dossiers
  • Training Feedback
  • Training Evaluation Form
Completion rules
  • You must complete the units "Exercises to EURS Session 1, Exercises to EURS Session 2, Exercises to EURS Session 3, Exercises to EURS Session 4, Exercises to EURS Session 5, Exercises to EURS Session 6, Exercises to EURS Session 7, Exercises to EURS Session 9, Exercises to EURS Session 11"
  • Leads to a certificate with a duration: 1 year
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