realizing the benefits of idmp
Post on 12-Apr-2017
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Realizing the Benefits of IDMP
These standards were developed in response to demand for internationally harmonized specifications for medicinal products. They support a variety
of regulatory activities related to:
Development Registration
Risk Management
Life Cycle Management
Pharmacovigilance
The IDMP standards define, characterize and uniquely identify regulated medicinal products for human use during their entire lifecycle, i.e. from development to authorization, post-marketing and renewal, or withdrawal from the market, where applicable.
What is IDMP?
The IDMP standards are based on a group of five ISO standards, which comprise health informatics data elements and structures for the unique identification and exchange of the following regulated articles:
What IDMP Means for the Industry
11615 Medicinal product information
11616 Pharmaceutical product information
11238 Substances
11239 Pharmaceutical dose forms, units of presenta- tion, routes of adminis- tration and packaging
11240 Units of measurement
Interaction of regulator with worldwide-maintained data sources
Interactions Supported by the IDMP Standards
Regulator to regulator
Pharmaceutical company to regulator
Sponsor of clinical trial to regulator
Regulator to other stakeholders
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2
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5
ISO - IDMP Association
Medical Product
Pharmaceutical Product
Substances
Dose forms,units of presentation,
routes of administration,Packaging
Units of Measurement
Group of 5standards
Substances,Specified Substances
Units of Measurements
Pharmaceutical Product (PhPID)
Dose FormRoute of Admin
Unit of PresentationPackaging
ISO 11615
ISO 11616
ISO 11238
ISO 11239
ISO 11240
Medicinal Product (MPID)
A Digital Transformation Platform for IDMP providesan in-depth understanding of the interrelationship of the various data elements in the data model.
To get process management and improvement underway, each organization must map existinginformation stores and integrate them to meet the requirements of the IDMP data model.
Identifying and agreeing on the primary sources of each data element, across the organization, is imperative to establishing a single source of truth.
A Digital Transformation Platform for IDMP
People, process, and data are the core of Appian’s approach, interlacing these three items together on one easy to use interface with Appian’s Records
feature. Records get all interested parties to comply to a single source of truth and facilitate acceleration of the product life cycle in order
to get drugs to market faster.
The Importance of Records
Example of interested partieslinked by Records:
Products Submissions
VendorsClinical Trials
Regulatory Deficiencies
PatentsExcipients CROs
Employees 483sLaboratories
SubstancesSuppliers Manufacturing Plants
Appian Records provides an intuitive ad-hoc way to integrate metadata and provide views that were previously unavailable, across multiple elements so users can visualize how they are
connected. The beauty of Appian’s Records is that it goes beyond just data visualization, and goes further to connectingthese elements together with your people and the processes.
Benefits of Appian Records
With Appian You Can:
Provide a single sourceof truth across data elements.
Facilitate the overall process of building the data model.
Support the leaders tasked with anorchestration of IDMP efforts, and
those needing top level views of howthe organization is doing as a whole.
Support others involved and served by the IDMP processes, including
members of regulatory, manufacturingor quality organizations.
Learn More
appian.com/blogwww.appian.com/pharma
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