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EURS Implementation Group

EURS Implementation Group. Terms of Reference and Roadmap. Terms of Reference & Roadmap. Context of the Group – Telematics Infrastructure Interface with other groups Interaction with IABG Interaction with other vendors In scope for discussion Out of scope for discussion

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EURS Implementation Group

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  1. EURS Implementation Group Terms of Reference and Roadmap

  2. Terms of Reference & Roadmap • Context of the Group – Telematics Infrastructure • Interface with other groups • Interaction with IABG • Interaction with other vendors • In scope for discussion • Out of scope for discussion • Industry involvement • Working practices – responsibilities of group members • Deliverables • High level roadmap

  3. Context of the Group – Previous EURS Meetings • Ad-hoc EURS group first formed in August 2003: • Representatives from all MS invited, via the TIGes • In the context of the then procurement procedure • Primarily to give MS and EMEA the opportunity to test and select a shared review tool for eCTDs • Opportunity to bring experts from MS and EMEA together to discuss implementation issues associated with the eCTD • Group met several times over the next 3 years, through 2 further procurement procedures, culminating in the selection of EiY in Decemebr 2006

  4. Context of the Group – Telematics Structure (1) • Following conclusion of procurement procedure 2006-34-PM and the selection of EiY, work of ad-hoc EURS Group formally complete • With a chosen shared review tool and more experience of eCTDs and awareness of issues, progress necessitates the formation of a new EURS Implementation Group, under TIGes umbrella

  5. Context of the Group – Telematics Structure (1) Telematics Steering Committee Telematics Management Committee Joint Implementation Group for e-Submission (TIGes) Other Telematics Implementation Groups Guidance Harmonisation Group Interlinking Groups PIM Core Team EURS Implementation Group eSubmission Website Group Roadmap Group

  6. Context of the Group – Telematics Structure (2) TIGes Mandate • The TIGes should facilitate and enable ICH-eCTD implementation in Europe through the development of standard specifications for electronic data exchange consistent with ICH specifications and European business requirements, as well as through development of requirements for IT systems that would enable implementation of the standards and the submission, validation and evaluation of applications for marketing authorisation using eCTD.

  7. Context of the Group – Telematics Structure (3) Sub Group Composition The TIGes may constitute working subgroups to addres specific issues within its remit and on its own authority. It will receive the reports of the subgroups, and incorporate the work of such subgroups as it sees fit. The TIGes subgroups shall comprise: • TIGes members (or other MS representatives nominated by TIGes members) • Invited industry representatives nominated by industry associations. The broadest possible representation of industry sectors should be sought.

  8. Interface with Other Groups (1) • 5 Other sub (topic) groups of the TIGes exist: • Lifecycle Management Group • Roadmap Group • Harmonisation of Guidance Group • PIM Core Team • eSubmission Website Group • EURS Group has specific responsibility for the implementation of the EURS • All groups report to the TIGes • eCTD Interlinking Group (NTA) also reports back to the TIGes

  9. Interface with Other Groups (2) • Is there overlap with existing topic groups? • Essential to establish the Terms of Reference for the EURS Implementation Group • Primary responsibilities of other sub-groups: • LCM Group: mandate to establish processes and requirements for LCM for all agencies and all procedures • Has not convened yet • Is LCM something the EURS implementation group can work on, as LCM is heavily associated with functionality provided by review tools? • Obviate the need for a specific LCM Group? • ….

  10. Interface with Other Groups (3) • … • Roadmap Group: Mandate to develop the joint roadmap for eCTD implementation in preparation for 2009 deadline (including workflow and archiving requirements); ensure that milestones are reached and roadmap is followed • To provide guidance towards achieving the target timeline endorsed by the Heads of Medicines Agencies, namely the acceptance of paperless submissions using the eCTD as the format for submission of the dossier for MA by 2009. • Has been working steadily in 2007 • Complementary work to the EURS Group, although establishment of systems and processes to store and review eCTDs is a crucial pre-requisite to implementation • EURS implementation is a key milestone in the roadmap • ….

  11. Interface with Other Groups (4) • …. • Harmonisation of Guidance Group: Mandate to reduce unilateral development with regard to eCTD implementation; develop harmonised and consistent implementation guidance both for the eCTD and the Non eCTD Electronic Standard (NEES) • Define requirements and business rules for eCTD and for Non-eCTD submissions as a transition to eCTD: • Has met several times and has been working steadily in 2007 • Working on a harmonised eCTD guidance document • Starting analysis of the NEES and associated guidance/requirements • Separate work to the EURS Group – although EURS group may produce harmonised guidance for using a shared review system • Group also looking at shared validation requirements – should be reflected in harmonised EU validation criteria that are implemented in the validation engine of the EURS and published • ….

  12. Interface with Other Groups (4) • …. • PIM Core Team:Mandate to define and follow the project plan for the implementation of the adopted PIM data exchange standard, obtaining approval from relevant bodies (e.g. TIGes-J, QRD WG, CMD(h) CHMP): • Further develop the PIM data exchange standard for the electronic submission and review of product information in the European Union, in accordance with implicated groups (e.g. QRD WG and CMD(h)) • Actively communicate progress on the project across all stakeholders • Has been working since 2003 • Much of the requirements gathering in terms of legal/process requirements for working with a centralised architecture for management of product information for CP can be applied to the implementation of a central repository for esubmissions (archiving, access, backup requirements) • Important consideration of interface between PIM Review System and EURS for integrated assessment • ….

  13. Interface with Other Groups (5) • …. • eSubmission Website Group: Mandate to define content and ensure publication and maintenance of the EU website for eSubmission http://esubmission.emea.europa.eu/ • Regular updates from the EURS Group should be communicated to the website group, and deliverables should be published as appropriate (EURS specifications, guidance documents, white papers, strategy/policy documents, SOPs etc). • Feed back via TIGes

  14. Interface with Other Groups (6) • … • eCTD Interlinking Group: Mandate to develop EU regional electronic standards (M1 and Application Form) aligned to paper standards; analysis of business and technical requirements for electronic standards; development of guidance for implementation of electronic standards; management of Change Requests/Q&A for eCTD implementation: • Has been meeting monthly for several years • Representation from TIGes and NTA WG • Responsible for the development, review and release of M1 and EU Application Form specifications (EU M1 current v1.2.1, New eAF v2.1, eAF-Var v1.1, eAf-Ren v1.0) • Some potential overlap with EURS group in discussion of business process for working with electronic submissions (access to submissions, lifecycle management) • ….

  15. Interface with Other Groups - Summary • EURS Group is complementary to other TIGes Sub-Groups • Potentially some overlap (LCM Topic Group) in terms of development of requirements for LCM • Potentially some overlap (eCTD Interlinking) in terms of development of process guidance/SOPs • Important to keep abreast of activities/deliverables of other groups – there may be more activities that arise in the context of one group that are transferred to EURS as the more appropriate forum and vice-versa • Report to TIGesquarterly

  16. Interaction with IABG • IABG is under contract with EMEA, and • IABG is primarily responsible for implementation of the chosen EURS and the central repository • IABG will be present at each meeting • Much contact will be directly between MS and IABG with regard to installations; important that monitoring/reporting is brought back up to the level of the implementation group, particularly shared issues

  17. Interaction with Other Vendors (1) • One other vendor has requested that a representative from the company becomes a member of the EURS Group. Justification for this: • Vendor serves some Member states with docuBridge as the local Submission Management System • Vendor has ongoing progress in local and central requirements • It would be for the benefit of member states who wish to use other tools to access the future central repository.

  18. Interaction with Other Vendors (2) • Is considered inappropriate to invite only one other vendor to meetings aside from the contracted EURS provider • All or none should be invited to participate out of fairness • Deliverables that contain information relevant to other vendors should be published and made available to all vendors e.g.: • Review tool requirements (via revised EURS specifications) • Central repository white paper – strategy, issues • Requirements for access to central repository using other tools

  19. In scope (1) • Proposed subjects that are in scope for discussion by the group: • Installation of EiY and other tools in all MS: • Timelines • Planning • Issues • Requirements • Integration with electronic workflow management systems and related systems (e.g. PIM)

  20. In scope (2) • Proposed subjects that are in scope for discussion by the group (continued): • Requirements specific to EiY • SOPs for use of EiY for all procedures • eCTD review and processing requirements/processes that are relevant to all tools • Lifecycle Management – use of metadata, management of eCTDs, lifecycle views in tools • Workflow and the place of eCTD in this • Migration requirements, process, issues – EMEA and MS • Archiving requirements, process, issues – EMEA and MS • Management of non-eCTD electronic submissions in EiY (and other tools) • Process issues

  21. In scope (3) • Proposed subjects that are in scope for discussion by the group (continued): • Central Repository for eSubmissions in the Centralised Procedure • Strategy • Planning • Identification and resolution of issues: • Process, • Technical, • Legal/political • Ad hoc issues that relate to the use of review tools for esubmissions (e.g. DTD migration and resolution for LCM)

  22. Out of Scope • Proposed subjects that are out of scope for discussion by the group: • Development of the eCTD specifications and related standards • eCTD Guidance related to the specifications (e.g. eCTD granularity, how to build and submit eCTDs) • Process issues relating specifically to electronic submission handling for MRP/DCP/national procedures (unless of joint relevance)

  23. Industry Involvement • Currently, EGA, EuropaBio and EFPIA and represented in the group (5 participants) • Is proportional/wider representation required in view of the proposed terms of reference, objectives and discussion topics? • Formation of a full joint implementation group?

  24. Responsibilities of Group Members • Representation of respective agency/industry association – active participation in meetings • Presentation of national requirements vis a vis EURS, central repository for CP • Presentation of status of local implementation of eCTDs, presentation of issues • Dissemination of information to colleagues – act as a conduit for information • Awareness of all issues relating to the work of the EURS Group that should be channelled to this group or other related groups • Establish an inventory of local information systems affected by the introduction of the EURS • Study the impact of the EURS on local information systems and establish resulting local requirements • Refer issues, points for clarification, lists of questions, etc. back to the Member State Competent Authority/industry association as and when appropriate • Active review of documentation – specifications, requirements, white papers etc • Participation in testing if appropriate • Active assistance in production of deliverables – requirements, SOPs etc.

  25. Deliverables • Status Update – EURS/eCTD review tool implementation • Updated EURS specifications – for publication • Specific SOPs related to the use of the EURS • Specific requirements related to the EURS • Lifecycle management requirements • Central repository: • Strategy/White Paper • General planning • Issues List • Requirements (business and technical, inc. migration and archiving) • Test plan • SOPs and process descriptions for use of the Central Repository for CP • Other?

  26. High Level Roadmap

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