European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, product, organisation and referential data (SPOR) task force meeting

• Date:
  Friday, 22 June 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The EU ISO IDMP / SPOR data task force is meeting with representatives from EMA, national competent authorities, pharmaceutical industries associations, terminology organisations, software vendors and developers of medicinal products dictionaries or databases to discuss the planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

Documents

Agenda - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting

Reference Number: EMA/289228/2018

Minutes - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting

Reference Number: EMA/471122/2018

Presentation - Product Management system (PMS) update

Presentation - Feedback to Substance, Product, Organisation and Referential data (SPOR) task force on EU-SRS

Presentation - Type IA notification process optimisation - Regulatory Optimisation Group (ROG) presentation to Heads of Medicines Agencies (HMA)

Presentation - Submission of legacy data - Veterinary

Presentation - New veterinary regulation (NVR): impact on Information Technology / Telematics (Jos Olaerts, Jana Schalansky)

Presentation - Industry points for discussion

Presentation - Substance, Product, Organisation and Referential data (SPOR) - Referentials Management Service (RMS) and Organisations Management Service (OMS) communication update