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Tutorial 01: IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

Nov 20 2013 9:00AM - Nov 20 2013 5:00PM | DoubleTree by Hilton (formerly The Burlington Hotel) Upper Leeson Street Dublin 4 IRELAND

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Overview 

Many national and international groups are developing standards for controlled vocabularies to identify medicinal products, substances and medical devices, including IDMP. Applying these standards to obtain a consistent and transparent medicinal product database internally will be a laborious and challenging task. Having experienced the difficulties with XEVMPD showed the need for companies to get ready for ISO IDMP well in advance of the implementation date. This tutorial provides attendees with a business case of establishing a controlled vocabulary, to be used as single source of truth in the various stages of a product lifecycle. This vocabulary will support all relevant disciplines and all types of exchange of information concerning the product’s quality, safety and efficacy. As a bonus the company will be ready to comply with ISO IDMP.

Learning Objectives

At the conclusion of this tutorial, attendees will be able to:

  • Familiarise themselves with the objectives of ISO IDMP in particular and controlled PI vocabularies in general
  • Inventory national and international drug dictionaries and standards
  • Develop metadata definitions, granularity, unique identification and data relationships
  • Define master data ownership and process to build a reliable vocabulary
  • Prepare for ISO IDMP
  • Establish your company-specific controlled vocabulary

Target Audience

Professionals involved in the following areas:

  • RA-CMC
  • Pharmacovigilance
  • Regulatory Information Managers
  • RA labelling
  • QPPVs and QP CMC
  • Regulatory IT
  • Manufacturing professionals
  • SAP Solution Managers
  • Pharmaceutical development professionals
  • Medical device managers
  • Regulatory operations
  • CROs
  • Clinical development
  • Software developers

Who Should Attend 

Professionals involved in the following areas:

  • RA-CMC
  • Pharmacovigilance
  • Regulatory Information Managers
  • RA labelling
  • QPPVs and QP CMC
  • Regulatory IT
  • Manufacturing professionals
  • SAP Solution Managers
  • Pharmaceutical development professionals
  • Medical device managers
  • Regulatory operations
  • CROs
  • Clinical development
  • Software developers

Learning Objectives 

At the conclusion of this tutorial, attendees will be able to:

  • Familiarise themselves with the objectives of ISO IDMP in particular and controlled PI vocabularies in general
  • Inventory national and international drug dictionaries and standards
  • Develop metadata definitions, granularity, unique identification and data relationships
  • Define master data ownership and process to build a reliable vocabulary
  • Prepare for ISO IDMP
  • Establish your company-specific controlled vocabulary

Instructor(s) 

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