EURS Implementation Group

1. EURS Implementation Group Introduction and Objectives

2. Introduction • Describe context of the meeting • Introduce members of the group • Establish objectives of meeting

3. 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

4. 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)

5. EURS Concept of Operations

6. 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.

7. 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.

8. 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.

9. 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

10. 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).

11. 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

12. 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

13. 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.

14. Introduction of Group Members (2) • EMEA Representatives: • Post-authorisation • Safety and Efficacy of Medicines • Regulatory Affairs (Central Information Group) • Quality of Medicines

15. 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

16. 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

17. 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

18. 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

19. 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