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

1

2

3

4

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

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