How IDMP can help structure Product / Labeling Information ...uanotau.com/onewebmedia/DC DIA Poster...
1
Life Sciences Rules and Specifications Life Sciences Business Templates Life Sciences Master Entity Network Life Sciences Content & Processes Life Sciences Internal View Life Sciences External View Objective: Demonstrate how IDMP data / entity model influences granularity of Product Information / Labeling Method: The study analyses IDMP data / entity model in context of granularity of Product Information / Labeling content How IDMP can help structure Product / Labeling Information Romuald Braun | Managing Director, uanotau ltd | VP Strategy, INFOTEHNA Life Sciences Building Blocks Master Data Disclosure: Romuald Braun: nothing to disclose Copyright © 2015 | uanotau ltd | Neuhofstrasse 3a | CH - 6340 Baar | p: +41 76 38 39 319 | [email protected] | www.uanotau.com Regulatory CMC Manufacturing Ph-vigilance Labeling Commercial Clinical Underlying Objects and their basic dependencies: Profiles, DocTypes, Life Cycles, Workflows, Users, Tables/Lists, Entity Model Objects, Basic Templates, Fragment, Document, Structure Rules for Entity Models transformation (e.g.), Creation of country specific / trigger submission templates, Transformation of Internal Entity Models / Structures to External Specifications (eCTD, XEVMPD, IDMP, SPL), Interfaces / Attributes Combination/Enrichment) / SOAP Rules, Tags (References to Entity.Field) / Transformation to XML, Reports / Workspaces (Tree, Frame SetUp, Tabs) Product Life Cycle Management Entity Model, (Taxonomies) Currently driven by IDMP requirements, including country entities Vocabularies, Templates of Model for different Product Types (Pharma, Devices), Internal/External Specifications:EDM REF, STED, eCTD / RPS, XEVMPD / IDMP, SLP / Labeling Creation and Management of Entities according to PLC Entity Model. Management of Entity types (Country, Manufacturer, Substance, Package, …) Creation and Management of Content Template Entities (using Tags): Fragments (RTF) (Labeling, CMC), Documents (Page oriented) Structures (VD’s) (Components, Submissions, Technical File, STF, Master Files, Labeling, LOD, DEVI/CAPA/CR) Management of Process Entities: DMS (R&D Pharma / Devices, Quality) / Structured Authoring (Labeling) Submission - Pharma (eCTD, NEES) / Clearance / Certification - Devices (510k, STED) QMS (DEVI / CAPA / CC …) / RIM (PLCM, R. Program, R. Project, R. Activity), IDMP (Dev. Product, Med. Product) / PhV (ICSR) eMPD Submissions (XEVMPD, IDMP) / PhV (ICSR), Labeling Documents, MAA Submissions (IND / CTA, PSUR, eCTD / NEES, RPS, Paper (PDF)), Clearance/Certification (510k, STED) <<<< <<<< 0 2 7 6 4 2 8 9 9 8 Other Product Instances In the last 30 years, the Life Sciences industry has been managing content, processes and data in separate applications. Solutions built on Documentum have defined this platform as de facto standard for content management in the industry. Documentum offers all the required entity management capabilities like versioning, life cycle management and workflow out of the box. On the other hand, process and data support has been reflected in data base applications following the standard entity relationship rules. Implementation of such data base applications seemed faster, however it often does not reflect the requirement to store the history of the model in the system. Integration between those two worlds was possible only by using custom interfaces, initially implemented as point to point interfaces, later utilizing services oriented architecture (SOA). Both approaches led to increased complexity and exponential maintenance effort of those systems and interfaces. IDMP is currently seen as the enabler of data model standardization, and the transition is an opportunity for many companies to verify or define the master data model. Analysis of the IDMP data model allows identification of multiple entities which are commonly used in other process areas, such as: • Management of marketing authorization relevant documents • Creation of marketing authorization submissions • Product information content • Documentation of clinical trials • Safety and pharmacovigilance content and reports • Quality control records and content • Marketing documents The use of "Integral by Design" model within solutions for managing content, processes and data enables an entity oriented approach: processes and data can therefore be managed within the same entity model. Key principles of the "Integral by Design" architecture are: • One entity model reflecting all required entities and the relationships between them • Management and control of all entities to allow full record track of the model • Painless configuration which enables quick adjustment to changing business rules • Flexibility in extending granularity of the content / data • If possible, one repository for all content, process and data entities Considering those principles, the "Integral by Design" model champions major synergies compared to the traditional model. Taking IDMP as master data standardization driver, the following synergies could be identified: • The IDMP data model can be used to drive the granularity of the repository • The internal granularity can be much higher than the granularity required by regulations or guidelines • Once in the system, all entities can be versioned and life cycled, allowing full record track • Master data can be used as meta data in multiple modules of an "Integral by Design" application. IDMP drives the granularity of data and content in the repository. The borders between data and content start to disappear as data starts to automate creation of ever smaller content fragments. Both the new Data Model Granularity and the Structured Authoring paradigm will require some adjustments in business processes. Change Management principles will have to be used on all levels, as small changes in data or content may have a big impact on the resulting structures. Labeling seems to be the easiest use case: Product Identification vs. Product Information 4 4 Product 2 Fragments Documents Structures Product 1 Fragments Documents Structures 4 3 SPL Template PIL Template SMPC Template CCDS Template 4 SPL Transform Rules Labeling Transforma tion SPL Specification PIL Specification SMPC Specification CCDS Specification 1 1 Labeling Rules Labeling Workspace 9 5 6 7 SPL PIL SMPC CCDS 8 Other Documents / Structures Master Data Rules Master Data Rules Product 2 Instances Product 1 Instances 4 3 Internal Entity Model 4 Master Data Rules Master Data Connect Rules Master Data Transform Rules Master Data Consolid. Rules IDMP Specification 7 1 6 IDMP Transform Rules IDMP Ack. and Transm. Rules 1 IDMP Rules Product Workspace 9 6 5 IDMP Submission 7 8 Other Product Instances
Transcript of How IDMP can help structure Product / Labeling Information ...uanotau.com/onewebmedia/DC DIA Poster...
Life SciencesRules and Specifications
Life Sciences Business Templates
Life Sciences Master Entity Network
Life Sciences Content & Processes
Life SciencesInternal View
Life SciencesExternal View
Objective:Demonstrate how IDMP data / entity model influences granularity of Product Information / Labeling
Method:The study analyses IDMP data / entity model in context of granularity of Product Information / Labeling content
How IDMP can help structure Product / Labeling Information Romuald Braun | Managing Director, uanotau ltd | VP Strategy, INFOTEHNA Life Sciences
Building Blocks Master Data
Disclosure:Romuald Braun: nothing to disclose
Copyright © 2015 | uanotau ltd | Neuhofstrasse 3a | CH - 6340 Baar | p: +41 76 38 39 319 | [email protected] | www.uanotau.comRegulatory CMC Manufacturing Ph-vigilance Labeling Commercial Clinical
Underlying Objects and their basic dependencies: Profiles, DocTypes, Life Cycles, Workflows, Users, Tables/Lists, Entity Model Objects, Basic Templates, Fragment, Document, Structure
Rules for Entity Models transformation (e.g.), Creation of country specific / trigger submission templates, Transformation of Internal Entity Models / Structures to External Specifications (eCTD, XEVMPD, IDMP, SPL), Interfaces / Attributes Combination/Enrichment) / SOAP Rules, Tags (References to Entity.Field) / Transformation to XML, Reports / Workspaces (Tree, Frame SetUp, Tabs)
Product Life Cycle Management Entity Model, (Taxonomies) Currently driven by IDMP requirements, including country entitiesVocabularies, Templates of Model for different Product Types (Pharma, Devices), Internal/External Specifications:EDM REF, STED, eCTD / RPS, XEVMPD / IDMP, SLP / Labeling
Creation and Management of Entities according to PLC Entity Model.Management of Entity types (Country, Manufacturer, Substance, Package, …)
Creation and Management of Content Template Entities (using Tags):Fragments (RTF) (Labeling, CMC), Documents (Page oriented)Structures (VD’s) (Components, Submissions, Technical File, STF, Master Files, Labeling, LOD, DEVI/CAPA/CR)
Management of Process Entities: DMS (R&D Pharma / Devices, Quality) / Structured Authoring (Labeling)Submission - Pharma (eCTD, NEES) / Clearance / Certification - Devices (510k, STED)QMS (DEVI / CAPA / CC …) / RIM (PLCM, R. Program, R. Project, R. Activity), IDMP (Dev. Product, Med. Product) / PhV (ICSR)
eMPD Submissions (XEVMPD, IDMP) / PhV (ICSR), LabelingDocuments, MAA Submissions (IND / CTA, PSUR, eCTD / NEES, RPS, Paper (PDF)), Clearance/Certification (510k, STED)
<<<<
<<<<
0 2
7
6
42
899 8
OtherProduct Instances
In the last 30 years, the Life Sciences industry has been managing content, processes and data in separate applications. Solutions built on Documentum have defined this platform as de facto standard for content management in the industry. Documentum offers all the required entity management capabilities like versioning, life cycle management and workflow out of the box. On the other hand, process and data support has been reflected in data base applications following the standard entity relationship rules. Implementation of such data base applications seemed faster, however it often does not reflect the requirement to store the history of the model in the system. Integration between those two worlds was possible only by using custom interfaces, initially implemented as point to point interfaces, later utilizing services oriented architecture (SOA). Both approaches led to increased complexity and exponential maintenance effort of those systems and interfaces.
IDMP is currently seen as the enabler of data model standardization, and the transition is an opportunity for many companies to verify or define the master data model. Analysis of the IDMP data model allows identification of multiple entities which are commonly used in other process areas, such as:• Management of marketing authorization relevant
documents• Creation of marketing authorization submissions• Product information content• Documentation of clinical trials• Safety and pharmacovigilance content and reports• Quality control records and content• Marketing documents
The use of "Integral by Design" model within solutions for managing content, processes and data enables an entity oriented approach: processes and data can therefore be managed within the same entity model. Key principles of the "Integral by Design" architecture are:
• One entity model reflecting all required entities and the relationships between them
• Management and control of all entities to allow full record track of the model
• Painless configuration which enables quick adjustment to changing business rules
• Flexibility in extending granularity of the content / data
• If possible, one repository for all content, process and data entities
Considering those principles, the "Integral by Design" model champions major synergies compared to the traditional model. Taking IDMP as master data standardization driver, the following synergies could be identified:
• The IDMP data model can be used to drive the granularity of the repository
• The internal granularity can be much higher than the granularity required by regulations or guidelines
• Once in the system, all entities can be versioned and life cycled, allowing full record track
• Master data can be used as meta data in multiple modules of an "Integral by Design" application.
IDMP drives the granularity of data and content in the repository. The borders between data and content start to disappear as data starts to automate creation of ever smaller content fragments.
Both the new Data Model Granularity and the Structured Authoring paradigm will require some adjustments in business processes. Change Management principles will have to be used on all levels, as small changes in data or content may have a big impact on the resulting structures.
Labeling seems to be the easiest use case: Product Identification vs. Product Information
4
4
Product 2FragmentsDocumentsStructures
Product 1FragmentsDocumentsStructures
43
SPL Template
PIL Template
SMPC Template
CCDS Template
4
SPLTransform
RulesLabeling
Transformation
SPL Specification
PIL Specification
SMPC Specification
CCDS Specification
1
1Labeling Rules
Labeling Workspace9
5
6
7
SPL
PIL
SMPC
CCDS
8
OtherDocuments / Structures
Master DataRules
Master DataRules
Product 2 Instances
Product 1 Instances
4
3 InternalEntity Model 4
Master DataRules
Master Data
Connect Rules Master
DataTransform
Rules Master Data
Consolid. Rules
IDMP Specification
7
1
6
IDMP Transform
Rules IDMP Ack. and
Transm.Rules
1
IDMP Rules
ProductWorkspace 9
6
5 IDMPSubmission
7
8
OtherProduct Instances
![The building blocks of IDMP implementation - Deloitte US · Directive, ISO Individual Case Safety Report [ICSR], electronic application forms ... The building blocks of IDMP implementation](https://static.fdocuments.us/doc/165x107/5b5064ec7f8b9a206e8e7b05/the-building-blocks-of-idmp-implementation-deloitte-us-directive-iso-individual.jpg)
