European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting (Dec 2018)

• Date:
  Tuesday, 4 December 2018, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The European Union (EU) International Organisation for Standardization (ISO) identification of medical products (IDMP) / Substance, Product, Organisation and Referential (SPOR) data Task Force meeting with representatives from the European Medicines Agency, national competent authorities, pharmaceutical industries associations, terminology organisations, software vendors and developers of medicinal products dictionaries / databases discussing aspects of 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.

Name of medicine	Doptelet
International non-proprietary name (INN)	avatrombopag
Marketing-authorisation applicant	Dova Pharmaceuticals Ireland Limited
Therapeutic indication	Treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure

Documents

Agenda - Substance, Product, Organisation and Referential data (SPOR) Task Force meeting (Dec 2018)

Reference Number: EMA/790603/2018

Minutes - European Union (EU) International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting (Dec 2018)

Reference Number: EMA/881990/2018

Presentation - Target Operating Model update to SPOR task force

Presentation - EU-SRS project update

Presentation - New veterinary regulation: impact on IT/Telematics

Presentation - SPOR data services update