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Release Notes 1.2.0

Release Notes 1.2.0

Oct 07, 2024

Ontology Development

Summary

Qualitative View

This quarter our focus was on bug fixing, usability, and simplification, in preparation for extensions supporting additional use cases in Q3. Analysis done over several weeks led to the conclusion that certain constructs, including some related to packaging, could be simplified for ease of use as well as to increase representation and reasoning efficiency. Because of the complexity involved not only in the ontology but in the IDMP standards, we are unwinding certain parts of the ontology incrementally rather than in a single issue. Simplification efforts will continue into Q3, when we will also be adding a number of new constructs. New work will involve fleshing out details for concepts needed for use cases such as the EMA PMS Data Alignment PoC, filling in gaps where there are missing attributes, for example, for some parts of the model.

Quantitative View

No ontology was added or deleted.

The following ontologies were revised and/or extended:

 

Ontologies

Deleted Resources

New Resources

Modified Resources

Ontologies

Deleted Resources

New Resources

Modified Resources

AmlodipineExample

0

0

7

doco

0

0

14

DocumentComponents

0

0

5

EuropeanRegistrationAuthorities

0

0

13

ISO1087-TerminologyScience

0

0

1

ISO1087-VocabularyForTermsAndDefinitions

0

0

2

ISO11238-RegistrationAuthorities

0

0

11

ISO11238-Substances

0

1

58

ISO11239-PharmaceuticalDoseForms

0

0

4

ISO11615-MedicinalProducts

3

5

57

ISO21090-HarmonizedDatatypes

0

0

6

Locations

0

0

4

MedicalDictionaryForRegulatoryActivities

0

0

2

MultipleVocabularyFacility

0

0

2

NorthAmericanRegistrationAuthorities

0

0

22

Organizations

0

0

9

po

0

0

8

ProductsAndServices

0

2

4

QlairaExample

0

0

5

QuantitiesAndUnits

0

2

9

RegistrationAuthorities

0

0

3

RegulatoryAgencies

0

0

4

StatisticalMeasures

0

0

3

SubstancesProductsOrganisationsReferentials

0

0

1

TerlipressinExample

0

0

1

Detailed View

resources in 1.1.0 but not 1.2.0 release

Ontologies

Resources

Ontologies

Resources

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/MeasurementReference

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/hasMeasurementReference

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/IntermediatePackaging

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/OuterPackaging

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ImmediateContainer

ISO11239-PharmaceuticalDoseForms

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/OuterPackaging

ISO11239-PharmaceuticalDoseForms

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ImmediateContainer

ISO11239-PharmaceuticalDoseForms

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/IntermediatePackaging

resources in 1.2.0 but not in v1.1.0 release

Ontologies

Resources

 

Ontologies

Resources

 

ISO11238-Substances

https://www.omg.org/spec/Commons/Documents/Specification

 

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ContainerRoleKind

 

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ContainerRole

 

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/OuterPackaging

 

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ImmediateContainer

 

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/IntermediatePackaging

 

ISO11239-PharmaceuticalDoseForms

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/IntermediatePackaging

 

ISO11239-PharmaceuticalDoseForms

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/OuterPackaging

 

ISO11239-PharmaceuticalDoseForms

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ImmediateContainer

 

ProductsAndServices

https://www.omg.org/spec/Commons/ProductsAndServices/isIssuedTo

 

ProductsAndServices

https://www.omg.org/spec/Commons/ProductsAndServices/isProvidedTo

 

resources modified from 1.1.0 to v1.2.0 release

Ontologies

Resources

Ontologies

Resources

ISO1087-VocabularyForTermsAndDefinitions

https://www.omg.org/spec/MVF/ISO1087-VocabularyForTermsAndDefinitions/ConceptField

ISO1087-VocabularyForTermsAndDefinitions

https://www.omg.org/spec/MVF/ISO1087-VocabularyForTermsAndDefinitions/SpecialLanguage

Organizations

https://www.omg.org/spec/Commons/Organizations/

Organizations

https://www.omg.org/spec/Commons/Organizations/OrganizationMember

Organizations

https://www.omg.org/spec/Commons/Organizations/OrganizationName

Organizations

https://www.omg.org/spec/Commons/Organizations/OrganizationalSubUnit

Organizations

https://www.omg.org/spec/Commons/Organizations/MemberBearingOrganization

Organizations

https://www.omg.org/spec/Commons/Organizations/FormalOrganization

Organizations

https://www.omg.org/spec/Commons/Organizations/OrganizationIdentifier

Organizations

https://www.omg.org/spec/Commons/Organizations/OrganizationPartIdentifier

Organizations

https://www.omg.org/spec/Commons/Organizations/Organization

RegulatoryAgencies

https://www.omg.org/spec/Commons/RegulatoryAgencies/Licensee

RegulatoryAgencies

https://www.omg.org/spec/Commons/RegulatoryAgencies/License

RegulatoryAgencies

https://www.omg.org/spec/Commons/RegulatoryAgencies/Licensor

RegulatoryAgencies

https://www.omg.org/spec/Commons/RegulatoryAgencies/

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/MedicalDictionaryForRegulatoryActivities/term/LLT/10067790

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/MedicalDictionaryForRegulatoryActivities/term/LLT/10002383

AmlodipineExample

https://spor.ema.europa.eu/v1/lists/100000000006/terms/100000062280-TermName-English

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlisterAsImmediateContainer

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBoxAsOuterPackaging

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/MedicalDictionaryForRegulatoryActivities/term/PT/10020772

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/ReferenceMaterial

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/SystemOfUnits

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/ScalarQuantityValue

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/hasMeasurementUnit

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/MeasurementProcedure

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/MeasurementScale

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/MeasurementUnit

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/SystemOfQuantities

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-3x28Box-AsOuterPackaging

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-6x28Box-AsOuterPackaging

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-28TabletBlister-AsImmediateContainer

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/Qlaira-PackageItem-1x28Box-AsOuterPackaging

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/QlairaExample/

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/NationalCancerInstituteThesaurus

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/ClinicalTrialsGov

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/DrugBank

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/RxNorm

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/UniversityOfCaliforniaSanFrancisoFederalDrugAdministrationTransport

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/CosmeticIngredientReviewDatabase

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/OrphanDrugProductDesignationDatabase

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/PlantListOfAcceptedNomenclatureTaxonomyAndSymbols

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/NationalCenterForBiotechnologyInformationTaxonomyDatabase

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/PubChem

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/GlobalSubstanceRegistrationSystem

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/IntegratedTaxonomicInformationSystem

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/LiverTox

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/ChemicalAbstractsServiceRegistry

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/MedicalSubjectHeadings

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/NationalDrugFileReferenceTerminology

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/PesticideProductInformationSystem

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/GermplasmResourcesInformationNetwork

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/InventoryOfEffectiveFoodContactSubstanceNotifications

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/NationalCenterForBiotechnologyInformationGeneDatabase

NorthAmericanRegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/NorthAmericanJurisdiction/NorthAmericanRegistrationAuthorities/USPharmacopeiaMedicinesCompendium

ProductsAndServices

https://www.omg.org/spec/Commons/ProductsAndServices/Site

ProductsAndServices

https://www.omg.org/spec/Commons/ProductsAndServices/

ProductsAndServices

https://www.omg.org/spec/Commons/ProductsAndServices/GS1Member

ProductsAndServices

https://www.omg.org/spec/Commons/ProductsAndServices/GS1CompanyPrefix

ProductsAndServices

https://www.omg.org/spec/Commons/ProductsAndServices/GlobalTradeItemNumber

po