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TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability - Vimarsana News

TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability

Published: March 20, 2023

There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help...

Source: clinicalleader.com
Related Topics:
Temple UniversityUnited StatesKen KeeferDrug Information AssociationStandards Governance CommitteeExchange Mechanism StandardJournal Of The European UnionReference Model Steering CommitteeGood Clinical Practice Inspectors Working GroupClinical Data Interchange Standards ConsortiumClinical Data Interchange ConsortiumStandards GroupTrial Master File Exchange Mechanism StandardExchange MechanismKeefer Consulting IncUniversity Of The SciencesEuropean Medicines AgencyHealth Level SevenKeefer ConsultingInvestigator Site FileSite Master FileClinical Trial RegulationModel To Enhance Industry WideReference ModelNeed For Data
In review: the life sciences regulatory regime in South Africa - Vimarsana News

In review: the life sciences regulatory regime in South Africa

Published: February 23, 2022

This article reviews the essential regulatory considerations surrounding medicines and medical devices in South Africa, including clinical trials and marketing authorisations.

Source: lexology.com
Related Topics:
South AfricaCape TownWestern CapeKwazulu NatalPort ElizabethEastern CapeRepublic Of South AfricaSouth AfricansSouth AfricanNational HealthNational Health Research Ethics CouncilHealth ProfessionsAfrican Pharmacy CouncilHealth Professions Council Of South AfricaSingle Convention On Narcotic DrugsNational Department Of HealthAfrican Medical Technology Industry AssociationUnited Nations ConventionAfrican National StandardAfrican Bureau Of StandardsConvention On Psychotropic SubstancesNational Prosecuting AuthorityAnimal Ethics CommitteeOffice Of Health Standards ComplianceMedicines Act