22nd May 2007 EURS Implementation Group Introduction and Objectives

22nd May 2007 Introduction Describe context of the meeting Introduce members of the group Establish objectives of meeting

22nd May 2007 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

22nd May 2007 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)

22nd May 2007 EURS Concept of Operations

22nd May 2007 Background – Implementation Strategy Phase IJuly – Dec. 2003Basic System in place based on file server and a commercially available eCTD viewing solution. Limited implementation. Phase IINov – Nov. 2006EURS 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 IIIFrom [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.

22nd May 2007 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.

22nd May – 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.

22nd May 2007 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

22nd May 2007 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).

22nd May 2007 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

22nd May 2007 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

22nd May 2007 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.

22nd May 2007 Introduction of Group Members (2) EMEA Representatives: –Post-authorisation –Safety and Efficacy of Medicines –Regulatory Affairs (Central Information Group) –Quality of Medicines

22nd May 2007 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

22nd May 2007 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

22nd May 2007 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

22nd May 2007 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

22nd May 2007 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