by Ursula Tschorn | Jul 14, 2015
Summary of Product Characteristics (SPC) sometimes also abbreviated as SmPC
by Ursula Tschorn | May 22, 2015
The FDA requires a “Stuctured Product Labeling” (SPL) for the registration of medicinal products. UNII Substances Unique Ingredient Identifier – a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance’s molecular...
by Ursula Tschorn | Mar 23, 2018
SPOR (as of 23.03.2018, Ursula Tschorn, IDMP SPOR Industry Change Liaison) SPOR is short for Substances Products Organisations and Referentials in the IDMP projects of the EMA. SPOR data services will act as the vehicle for implementation of ISO IDMP standards in the...
by Ursula Tschorn | Feb 17, 2017
RMS & OMS Mapping – Impact to Industry Concerning SPOR Data Mapping Activities the Industry is invited to start now with mapping activities. At the same time be aware, that the RMS and OMS lists are still worked on. The preparing activities are: SPOR Programme...
