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1

EU IDMP Task Force

The EMA and the EU Regulatory Network have founded an EU IDMP Task Force with the involvement of terminology organisations, software vendors and developers of medicinal products dictionaries or databases. The task force will be responsible for advising on the planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line […]

2

GINAS

Global Ingredients Archiving System (GINAS) What is GINAS in relation to ISO 11238 GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances.  GINAS supports all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the IDMP. […]

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IDMP Stakeholder Mindmap

IDMP is aimed to be used wide out of the regulatory silo. Actually it will close the circle between the regulatory and the e-health world. This is the tremendous value of IDMP for the health care market worldwide. IDMP is the base for identifying medicinal products uniquely across all stakeholders. IDMP Stakeholder Mindmap IDMP was […]

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ISO 11238

Regulated information on substances (ISO 11238) ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade). Substances can have different roles in medicinal products (e.g. active, adjuvant). They are identified via their molecular weight, structure and their unique […]