EURS Implementation Group

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EURS Implementation Group

• Terms of Reference and Roadmap

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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

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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

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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

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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
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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.

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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.

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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

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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?
• .

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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
• .

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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
• .

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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
• .

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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

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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/QA 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)
• .

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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/deliverabl
  es 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 TIGes quarterly

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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

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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.

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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

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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)

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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

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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)

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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)

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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?

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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.

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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?

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High Level Roadmap