PIM LAT by dfsiopmhy6


									                                   004-00014     Doc id:
    European Medicines Agency
   Communications and Networking    PIM LAT    EMEA/40824

        PIM LAT

            Version 1.0

                                                          004-00014     Doc id:
                           European Medicines Agency
                          Communications and Networking    PIM LAT    EMEA/40824

CONTENTS                                                                 2
ABOUT THIS DOCUMENT                                                      3
AIM                                                                      3
 SCOPE:                                                                  3
 OBJECTIVES AND DELIVERABLES                                             3
WORK STRANDS & PRIORITIES:                                               4
 (INTER)DEPENDENCIES                                                     4
    DES                                                                  4
    PRS                                                                  4
 KEY ISSUES                                                              4
COMPOSITION                                                              5
ROLES                                                                    5
   Co-Chairs                                                             5
   Industry Representative                                               6
   NCA Team representative                                               6
   EMEA and Development Team Representative                              6
   Stakeholders                                                          6
COMMUNICATIONS                                                           7
DOCUMENT INFORMATION                                                     7
 DOCUMENT LOCATION                                                       7
 DOCUMENT ID                                                             7
 REFERENCED DOCUMENTS                                                    7
 DOCUMENT HISTORY                                                        7
 REVIEWERS                                                               8
 DISTRIBUTION                                                            8

                                                                              004-00014            Doc id:
                                 European Medicines Agency
                                Communications and Networking                  PIM LAT           EMEA/40824

This document contains the Terms of Reference for the PIM Light Authoring Tool (LAT) Working
Group. The LAT WG is tasked with the development of the project Vision (EMEA/280732/2006),
specification of user requirements, review and approval of development team deliverables,
confirmation of testing and acceptance of the final product.

The LAT WG has been empowered by the CT to represent the views of the relevant parties. The
Working Group will analyse the need for future enhancements and application versions, and present its
conclusions to the PIM Core Team.

The PIM LAT Working Group is tasked to deliver the PIM Light Authoring Tool, which will be
implemented by the EMEA. The LAT is intended to realise the process and resource benefits for
Agencies and Applicants from the implementation of PIM by providing a readily available tool for
applicants to provide PIM submissions and receive commented submissions from the Agencies.

The PIM Light Authoring Tool is a minimal XML authoring tool to support PIM applications after
gathering an agreed set of requirements by all stakeholders.

The PIM Light Authoring Tool is described in the associated application documentation.
This tool is part of the EMEA's initiative to provide increased administrative assistance for small and
medium sized enterprises (SMEs) to enable them to adapt to changes and to new operating procedures
arising from European Union regulatory and legislative change. The underlying legislative basis of this
initiative may be found in Regulation (EC) No. 726/2004.

Development of the Light Authoring Tool for centralised, Mutual Recognition and Decentralised
(MRP and DCP) procedures and the validation engine to automatically validate the DES business rules;
evaluation of functionality according to the Vision document (EMEA/280732/2006), user acceptance
testing, input to Core Team for strategic decisions, e.g. release and/or public communication.

Objectives and deliverables
  The primary objective is the functional Light Authoring Tool, packaged in a manner that allows
  download, installation and use according the requirements defined by the WG in the development

  Key supporting deliverables include:
  o A Vision Document for the LAT (updated for each release) (EMEA/280732/2006)
  o An agreed upon common user requirement specifications for the LAT (EMEA/408242/2006)
  o Use Cases and UAT Test Scripts (EMEA/214563/2006)
  o Periodic reports to the Core Team
  o An Installation Manual for the application (EMEA/280201/2006)
  o A User Manual for the application (EMEA/408242/2006)
  o Training Materials

                                                                               004-00014            Doc id:
                                  European Medicines Agency
                                 Communications and Networking                  PIM LAT           EMEA/40824


Backwards compatibility
       Impact on database: changes to the DES may require new database structures within the LAT.
       Alterations to the internal LAT database structure impact the ability of the application to read
       prior saved versions of the data store.
       Impact on envelop fields: changes to the envelope fields of the DES will impact the ability of
       the LAT to import new PIM versions and to export valid PIM versions. This can require LAT
       development work.
       Impact on zone structure
       The LAT must be able to be updated if and when QRD templates are updated. The LAT
       validation engine and document templates must be able to work to the most recent QRD

LAT must import and work with any files exported from the PRS: must display any necessary
information (comments, metadata, etc.), must be able to import the most current PRS-supported DES

Export files for submission (-a versions) must be DES compliant at a minimum to a DES version
supported by the PRS. It does not need to be the most recent DES, but at least a supported version.
The current version of the LAT cannot create a non-PRS-supported –a exported version.

The LAT and PRS share underlying code. Change control for each must evaluate the impact on each.

Key Issues
Balancing minimal (“light”) tool requirements against scope creep: the goal of the LAT team is to
produce a light authoring tool as described in the PIM project documentation and as elucidated in the
Vision document. However, various stakeholders or application users may request further
functionality. It is the responsibility of the Working Group, and ultimately the Co-Chairs, to balance
these requests against the stated goals, and assess the criticality of the request for meeting the LAT

Getting adequate representation from SMEs: the LAT tool is intended to provide PIM capability to
small and medium sized enterprises. By definition SMEs do not have the resources of large
companies, and due to staffing levels and budget constraints it may be difficult for employees of an
SME to commit to participation in the LAT Working Group, especially with regard to travelling for
face-to-face meetings.

                                                                              004-00014             Doc id:
                                 European Medicines Agency
                                Communications and Networking                  PIM LAT            EMEA/40824

The PIM LAT Working Group is a sub-team of the PIM Core Team. Working Group deliverables will
be approved and released by the PIM Core Team, and project strategic goals, targets and constraints
will also be set by the Core Team.

The team will be co-chaired by industry and EMEA, and will report to the PIM Core Team.

The LAT Team comprises thirteen members:
       • Industry representation: Seven members with expertise in different classified products,
           including co-chaired and with labelling expertise. Two of them should be SME
       • EMEA: Four members. One co-chairing CT representative and project management
           expertise, one with QRD expertise and two consultants with technical expertise.

In addition, additional resources from both regulators and industry will be provided by the Core Team
and will co-exist with the permanent team when required and for the following activities:
         • Requirements clarification.
         • Testing and evaluation of test results.

These additional resources will not be members of the LAT Team.

Membership will include, at a minimum, one Core Team member (the internal business representative)
but may include more. Membership from industry should include representation from at least one
small- or medium-sized enterprise.


Responsibilities of the internal EMEA Co-Chair (and of the external industry Co-Chair if also a
member of the PIM team) as Core Team Representative:

  o   To provide to the Core Team input into the user requirement specification process;
  o   To refer issues, points for clarification, lists of questions, etc. back to the Core Team;
  o   To communicate Core Team project constraints or PIM strategic decisions that impact the LAT;
  o   To arrange communication of Core Team review & comment back to the Working Group;
  o   To manage the interface with the application development team;

The common responsibilities of the Co-Chairs are:

  o   To oversee the working practices of the LAT Working Group;
  o   To develop agreed common user requirement specifications among the various parties;
  o   To review and comment on relevant documentation discuss at Working Group meetings;
  o   To participate in tests of software deliverables;
  o   To introduce and review change requests, and ensure that the Working Group evaluates change
      requests according to the PIM Change Control Process;
  o   Be aware of all issues relating to the work of the LAT Working Group that should be channelled
      to the Core Team;
  o   Actively participate in the work of Business Team.
  o   Attend all meetings of the relevant Business Team or appoint a proxy, as appropriate.

                                                                               004-00014                Doc id:
                                  European Medicines Agency
                                 Communications and Networking                  PIM LAT               EMEA/40824
  Industry Representative
The working group will include representatives of applicants. Industry representatives will consist of
representatives from EFPIA, which has supported the PIM project from its inception, and from SME

The role of an industry representative includes:

  o   To arrive at agreed common user requirement specifications for the LAT;
  o   To provide industry input to the LAT WG as user requirements;
  o   To sign-off on agreed use cases
  o   To introduce and review LAT change requests based on applicant experience;
  o   To participate in tests of software deliverables;
  o   To represent industry in the final acceptance of LAT systems and documentation via the User
      Acceptance testing process (UAT). At a minimum three industry representative will participate
      in the sign off process of the UAT.
  o   To review and comment on relevant documentation generated by the Working Group;
  o   To act as conduits for the flow of project information back to industry organisation member
      companies (for EFPIA this will be accomplished via the PIM Implementation Network);
  o   Actively participate in the work of the Working Group, including coordinating any contributions
      from their own internal company resources;
  o   Attendance to Working Group meetings (and specify a pre-designated company delegate, as

  NCA representative
Provide support and expertise in the requirement gathering for MRP and DCP procedures as additional

  EMEA and Development Team Representative
EMEA will co-chair with industry and will have the responsibilities of the co-chair detailed above and
will assist to resolve QRD issues related within the LAT development and bug fixing processes.

The development of the LAT tool itself is provided by Trasys as part of the EMEA PIM tender.

Representatives of the LAT development team from Trasys will participate in the Working Group.

The responsibilities of the Development Team Representatives include:
  o Business analysis definition via the Vision and the users requirement document.
  o Translation of requirements on use cases (UCs) for LAT Team representative sign-off.
  o Development of the LAT tool based on the signed-off UCs including training material, user
      installation manual, user guide, ut, etc.

Stakeholders for the Working Group are comprised of the PIM Core Team, the EMEA, NCAs and
industry (applicants).

The PIM Core Team has delegated responsibility to the Working Group to manage the development of
the LAT, a key element in the overall PIM project.

The EMEA and NCA, as core stakeholders in the PIM project, are relying on the LAT to enable SME
applicants to utilise the PIM systems.

Industry, as a core stakeholder in the PIM project, is relying on the LAT to provide a PIM tool for
small and medium sized enterprises, and to prime the third-party vendor market.

                                                                                004-00014            Doc id:
                                  European Medicines Agency
                                 Communications and Networking                   PIM LAT           EMEA/40824

The Working Group will communicate to the PIM Core Team via the Internal Business Representative
(Co-Chair) and any PIM Core Team members present in the Working Group as participants. The PIM
Core Team will approve written deliverables for external communication.

The Working Group will maintain the content for the LAT section of the PIM web-site
(http://pim.emea.europa.eu/lat/index.html). The Working Group will deliver written communications
and project documents to the end-users of the LAT application via the web-site.

Industry representatives on the Working Group will be responsible for communication to their
respective industry organisations.

In order to be in line with the EMEA PIM core team ToR, do we need to add sections on the:
- Costs and funding
- Intellectual property rights
- Confidentiality
as the members of the LAT group do not all participate to the EMEA PIM core team.

Document location

Document id

Referenced documents

         Doc id                Date         Title
   EMEA/408242/2006        08-Sep-2006      PIM LAT Vision v2.0.1
   EMEA/347133/2006            TBD          PIM Terms of Reference
  EMEA/342717/2006             TBD          PIM Change Control

Key components of the existing LAT Document Set:
         Doc id                Date         Title
   EMEA/408242/2006        08-Sep-2006      PIM LAT Vision v2.0.1
   EMEA/408242/2006        08-Sep-2006      PIM LAT User Requirements v1.4
   EMEA/408242/2006        08-Sep-2006      PIM LAT 2.1.0 User Manual v1.7
   EMEA/280201/2006        20-July-2006     PIM LAT Installation Manual v2.4
   EMEA/408242/2006        20-July-2006     PIM LAT – UAT Business Scenario v1.1
NOTE: This is not an exhaustive list. Other documents will be created for particular purposes (such
      as release notes, technical specifications, use cases, test scripts, discussion documents, etc.).
      This table lists the critical documents for release to the public.

Document history
 Version       Who              Date                                     What
   0.1     R. Kupiec         11-Oct-2006      Initial draft
   0.2     J. Rueda          12-Oct-2006      Second Draft
   0.3     R. Kupiec         12-Oct-2006      Accepted most changes, added some more explanatory
                                              text and fixed minor errors.
   0.4     J. Rueda          26-10-2006       Review and accept comments and additions
   1.0     J. Rueda          17-11-2006       All comments incorporated
   1.1     J. Rueda          23-11-2006       SE coments incorporated

                                                                 004-00014             Doc id:
                      European Medicines Agency
                     Communications and Networking                PIM LAT            EMEA/40824

        Name           Date        Version                      Comments
J. Rueda            12-10-2006        0.1
R. Kupiec           12-Oct-2006       0.2            Changes from v0.1 now reflect the
                                                  proposed LAT WG going forward. This
                                                  is quite different from team structure up
                                                                   til now.
Corinne Pingal       26/10/2006       0.3                   Addition of comments
J. Rueda             26/10/2006       0.3
TIGes - SE           22-11-206        1.0         Coments on LAT composition for NCAs

        Name            Date          Version
J. Rueda            11-Oct-2006             0.1
LAT Working Group   12-Oct-2006             0.3
PIM Core Team        26/10/2006             0.4
TIGes-J             20-11-2006              1.0


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