Organisations: Reports from subgroup EU ISO IDMP Task Force meeting - - PowerPoint PPT Presentation

Organisations: Reports from subgroup

EU ISO IDMP Task Force meeting 25 September 2015

• 1. Progress report on subgroup activities
• 2. Phase I implementation of the operating model
• 3. Next steps

ISO IDMP Task Force 1 25 September 2015

Organisations - content

Work continued after summer break covering the following key items:

• Logical Data model
• Multi lingual support on organisation data
• Versioning of organisation records
• Definition of EU_Org_ID
• User management to request organisation registration/updates

ISO IDMP Task Force 2 25 September 2015

Progress report on subgroup activities

Logical Data model (work in progress):

• Support for multi-level organisation classification
• E.g. Higher Level = Industry/Pharma company, Sub_Level = SME, Lower Sub_Level =

Micro, Small or Medium, etc.

• Still to define the levels of classification to implement by business
• EU_Org_ID assignment on the address level
• The uniqueness of the ID to be based on the combination for unique organisation and

address.

• An organisation can have multiple sites/addresses
• Associations between organisations; organisations & individuals;

between individuals is possible

• E.g. A person linked to a Sponsor or MAH, linkage between two organisations after a

previous split, etc.

• Support for hierarchies amongst organisations

ISO IDMP Task Force 3 25 September 2015

Progress report on subgroup activities

Multi lingual support on organisation data (work in progress):

• The group agreed with supporting organisation data in ‘English’ only
• What does ‘English’ mean?
• Key elements to consider: Organisation name, Organisation address, City,

County/State/Region and Country.

• Agreed that Country can be stored only in English.
• Agreed that address will have to be accepted and stored in local/national language
• Debating whether organisation name, city and County/State/Region should be accepted

always in English (as preferred) but stored also in local/national language

• In principle, terminology used should be in Latin characters
• Support for additional characters particular to EU national languages but not in Cyrillic

and Greek

• Search functionality for organisations to follow the above principles

ISO IDMP Task Force 4 25 September 2015

Progress report on subgroup activities

Versioning of organisation records (work in progress):

• Multiple versions to be stored against the same EU_Org_ID
• Questions on what is exposed to users (web UI/API interface)
• For browse & search in dictionary, only current version?
• For download and export of dictionary, all versions?

EU_Org_ID definition (work in progress):

• Identifying all business scenarios which may trigger changes to

Organisation data

• Define business rules/criteria to issue new EU_Org_ID or create a

new version of existing ID.

• Define EU_Org_ID composition and format

ISO IDMP Task Force 5 25 September 2015

Progress report on subgroup activities

User Management (work in progress):

• Agreed that requesters for organisation registration/updates should

be authenticated and controlled

• Implementation of a ‘Super/Administrative User’
• Must be linked to a Sponsor, MA applicant or MAH
• This user is validated/authenticated by EMA
• They validate/assign access to other users linked to the same organisation on a self-

service approach

• All these users can then send requests for organisation registration/updates
• Requests for organisation registration and updates based on authenticated users
• A large number of users (super users) will need to be created at the

beginning – how not yet defined.

ISO IDMP Task Force

6 25 September 2015

Progress report on subgroup activities

ISO IDMP Task Force 7 25 September 2015

Phase I implementation of the operating model

Phase I - Organisations Operating Model – Implemented as part of the first OMS project

NCA EMA Industry

Scenario applicable when the Organisation data is submitted to NCA first and it doesn’t exist in EU hub (MDM) Submit application HL7 message containing: <EU_org_ID> <Organisation data> etc. If not registered, assign NCA_org_ID and validate against EU_org_ID MDM (EU Hub) Publish data in the

• rganisation dictionary

Request Organisation registration or update EU_org_ID and organisation data EU_org_ID and

• rganisation data

NCA_org_ID & EU_org_ID and

• rganisation data

Request for

• rganisation

registration or update

Pre-Registration of Organisation in the EU Organisation Hub

Request for

• rganisation

registration or update

Applications/information sent as part of regulatory activities

Register and issue EU_org_ID

• Conclude current discussions with a decision
• Start discussions on the implementation approach for the
• perating model
• Test the operating model to implement in this project with

sample data/real scenarios (use cases)

• Analyse possibilities to obtain manufacturers data from

additional sources to EudraGMDP e.g. EU national Agencies, FDA, EDQM, etc.

ISO IDMP Task Force 8 25 September 2015

Next Steps