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EURS Implementation Group. Introduction and Objectives. Introduction. Describe context of the meeting Introduce members of the group Establish objectives of meeting. The EURS: What Is It?. Eu ropean R eview S ystem

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Eurs implementation group

EURS Implementation Group

Introduction and Objectives


Introduction
Introduction

  • Describe context of the meeting

  • Introduce members of the group

  • Establish objectives of meeting


The eurs what is it
The EURS: What Is It?

  • European Review System

  • A common European solution for the validation, management and review of eCTDs (and non-eCTD electronic submissions)

  • A solution to be made available by EMEA for all agencies that choose to implement it.

  • Goal is to enable all agencies to have a shared view of submissions, and shared view of lifecycle, for harmonised management during joint procedures (Centralised, MRP):

    • To provide confidence during interactions

    • Shared awareness of how lifecycle may be viewed

    • Shared validation

  • Requirement for compatibility of output/input from builder tools to EURS

  • Aim to reduce unilateral development and facilitate joint procedures


The eurs what is it1
The EURS: What Is It?

  • No requirement for a dedicated review tool in order to the access the eCTD submission

  • eCTD is a self-contained standard –stylesheet means that a browser is the only requirement to navigate through the dossier and view information

  • However, without a dedicated review tool, no use can be made of the powerful LCM capabilities inherent in the eCTD

  • Important requirement of any ‘eCTD review tool’ is the ability to handle non eCTD electronic submissions also (majority of legacy submissions)



Background implementation strategy
Background – Implementation Strategy

  • Phase I July. 2003 – Dec. 2003 Basic System in place based on file server and a commercially available eCTD viewing solution. Limited implementation.

  • Phase II Nov. 2003 – Nov. 2006 EURS v1.0, in production for evaluation. Gathering of further requirements and subsequent implementation of EURS v1.1 via multiple tools, with more comprehensive functionality, as set out in specifications EMEA/2004/37/PM (October 2004). Implementation as wide as possible throughout EU NCAs.

  • Phase III From [Dec. 2006] EURS v2.0: Fully featured single-tool EURS in production. Based on full specifications following experience with the EURS v1.0/v1.1. Implementation as wide as possible throughout the EU NCAs.


Context of meeting history of eurs
Context of Meeting – History of EURS

  • December 2002: EURS v1.0 Requirements document published by TIGes.

  • 2003: EMEA procurement procedure to select an EURS for general implementation

  • A panel of EMEA representatives, MS assessors and MS IT experts met to evaluate the different tools presented

  • Opinion expressed that eCTD experience was not sufficient to confidently select a single tool for use

  • DocuBridge from Lorenz selected as an interim solution (for one year) to enable experience of tools and eCTD to be gained – felt to be the most mature tool at the time

  • 12 month interim contract set up, to November 2004.


2003 2004 docubridge interim solution
2003 - 2004 – docuBridge Interim Solution

  • docuBridge from Lorenz selected in the tender procedure as was then the preferred tool in terms of reviewer functionality – seen as most mature tool.

  • Users did not feel ready to commit to a long term solution (and support costs) before having real experience of eCTDs.

  • Agreement to pursue negotiated contract for ‘interim’ 12 month solution with Lorenz – shorter term solution.

  • Testing period to allow agencies to gain experience with real eCTD submissions using a review tool, and build advanced processing and review requirements.


Multiple tool approach 1
Multiple Tool Approach (1)

  • October 2004: A decision was taken by the EURS Group to continue with the installations and testing of docuBridge, for another year, but to make available to all NCAs 2 additional review tools:

    • eCTDXpress from ISI

    • ‘EURS is Yours’ from IABG


Multiple tool approach 2
Multiple Tool Approach (2)

  • No value seen in removing docuBridge from NCAs where installed – valuable experience being gathered

  • NCAs felt the need to gain exposure to different tools – at present, no ‘right’ or ‘wrong’ ways of handling eCTDs – just different interpretations

  • Exposure to different tools in business context will increase knowledge overall and enable a robust set of requirements to be finalised

  • Objective was to come to an agreement on a robust final EURS v2.0 set of requirements and go to tender for a definitive single tool by September 2005 – this eventually happened July 2006 (a contract extension was required).


Latest developments
Latest Developments

  • After a procurement procedure stretching from July 2006 – December 2006, a final commitment to a single review tool was made – EiY from IABG selected – unanimous decision

  • Assessors in many agencies currently still view/review eCTDs using a browser and a stylesheet rather than using a dedicated review tool, even though there may be one available:

    • Partly due to anticipation of a decision as to a final single tool for long-term usage?

    • Partly due to an ongoing development of understanding of LCM and the benefits of the eCTD and review tools?

    • Partly due to lack of full eCTDs to load into a review tool?

  • Objective is to turn this around with the implementation of a robust single review solution


Context of meeting
Context of Meeting

  • With the selection of a final EURS solution for long term implementation, the work of the EURS group in its previous incarnation is complete

  • EURS Group now re-constituted to reflect the new challenge of the EURS implementation phase (no longer in the context of a specific procurement procedure), including central repository implementation

  • Important to establish scope of work for the group, terms of reference, objectives and deliverables

  • Focussed meetings with clear deliverables


Introduction of group members 1
Introduction of Group Members (1)

  • Group of experts, EMEA and MS, representing different functions

  • Current or future users of the EURS with experience and/or knowledge of the Centralised Procedure as well as other procedures

    • Scientific assessors,

    • Procedure coordinators,

    • Administrators

  • Representatives with technical expertise

    • May be responsible for maintaining the tool internally and integrating with systems

  • All nominees should have experience and/or clear understanding of the eCTD standard and implementation issues.


Introduction of group members 2
Introduction of Group Members (2)

  • EMEA Representatives:

    • Post-authorisation

    • Safety and Efficacy of Medicines

    • Regulatory Affairs (Central Information Group)

    • Quality of Medicines


Introduction of group members 3
Introduction of Group Members (3)

  • 15 Member States, 2 candidate countries represented:

    • Austria

    • Belgium

    • Czech Republic

    • Denmark

    • France

    • Germany (PEI and BfArM)

    • Greece

    • Hungary

    • Lithuania

    • The Netherlands

    • Norway

    • Portugal

    • Spain

    • Sweden

    • United Kingdom

    • Croatia

    • Turkey


Introduction of group members 4
Introduction of Group Members (4)

  • Industry representatives from industry associations EFPIA, EuropaBio and EGA

    • Experience and/or a clear understanding/appreciation of the eCTD standard and implementation issues

    • Some practical experience of compiling, submitting and maintaining the lifecycle of eCTDs in European procedures


Main objectives of the group 1
Main Objectives of the Group (1)

  • Tool installation Monitoring and Management:

    • Management and discussion of the EURS contract

    • Monitoring of the installations of the IABG review tool under the conditions of the contract

    • Monitoring of the development of bespoke review tools or installation of other review tools by NCAs

  • Specific discussion of use of the IABG tool (selected EURS)

    • Development of processes and guidance regarding the use of the IABG review tool

    • Provision of a forum for questions regarding any aspect of use of the IABG tool

    • Development of further requirements for the IABG review tool


Main objectives of the group 2
Main Objectives of the Group (2)

  • Requirements development

    • Development and clarification of complex requirements e.g. lifecycle management

    • Documentation and publication of requirements

  • Provide a forum for discussion and resolution of issues (business and technical) associated with the implementation of the IABG tool, and other review tools, for use in all procedures

    • Consideration of workflow and the place of eCTD

    • Migration issues

    • Archiving issues

    • Management of non-eCTD electronic submissions

    • Process issues


Main objectives of the group 3
Main Objectives of the Group (3)

  • Implementation of the Central Repository for the Centralised Procedure

    • Strategy

    • Planning

    • Identification and resolution of issues:

      • Process,

      • Technical,

      • Legal/political


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