Transcript EURS Implementation Group

EURS Implementation Group
Terms of Reference and Roadmap
22nd May 2007
Terms of Reference & Roadmap
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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
22nd May 2007
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
PIM Core Team
EURS Implementation Group
eSubmission Website Group
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Roadmap Group
Interlinking
Groups
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:
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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)
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– 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)
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– 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:
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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)
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– 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)
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– 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)
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– 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)
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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/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 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:
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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):
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Requirements specific to EiY
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SOPs for use of EiY for all procedures
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eCTD review and processing requirements/processes that are relevant to all tools
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Lifecycle Management – use of metadata, management of eCTDs, lifecycle views in tools
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Workflow and the place of eCTD in this
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Migration requirements, process, issues – EMEA and MS
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Archiving requirements, process, issues – EMEA and MS
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Management of non-eCTD electronic submissions in EiY (and other tools)
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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
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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
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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:
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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?
22nd May 2007
High Level Roadmap
22nd May 2007