by Ursula Tschorn | Jul 13, 2015 | Abbreviations, E-Subscription, pharmazie.com Database
Periodic Safety Update Report (PSUR) The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and...
by Ursula Tschorn | May 22, 2015 | Abbreviations, E-Subscription, Structured Product Labeling - SPL
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...
by Ursula Tschorn | May 22, 2015 | Abbreviations, E-Subscription, Extended Eudravigilance Product Dictionary - XEVMPD
XEVMPD: The Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA): Controlled Vocabulary for Marketing Authorisation XEVMPD is the Extended Eudravigilance Medicinal Product Dictionary of the European Medicinal Agency (EMA) which...