by Ursula Tschorn | Aug 6, 2015 | Abbreviations, E-Subscription
Electronic Common Technical Document eCTD The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format. It was developed...
by Ursula Tschorn | May 22, 2015 | E-Subscription, Extended Eudravigilance Product Dictionary - XEVMPD, Structured Product Labeling - SPL
eSubscription is the process of registering medicinal products for marketing authorisation at the local authorities. eSubscription requires in current regulations in the US and Europe substantially different technologies, terminologies and vocabularies for...
by Ursula Tschorn | May 21, 2015 | E-Subscription, ISO IDMP Standards
Global Ingredients Archiving System (GINAS) What is GINAS in relation to ISO 11238 GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances. GINAS supports all substance types described in the 11238...
by Ursula Tschorn | Jul 17, 2015 | E-Subscription, Structured Product Labeling - SPL
Lot Distribution Report LDR In US under 21 CFR 600.81, marketing authorisation applicants must submit to the Center for Drug Evaluation and Research (CDER), LDRs containing certain specified information every 6 months about the quantity of the product distributed...
by Ursula Tschorn | Jul 30, 2018 | E-Subscription
Periodic Adverse Drug Experience Report PADER Post-approval cumulative reports of safety include Periodic Adverse Drug Experience Reports (PADERs) in the U.S. and Periodic Safety Update Reports (PSUR) in many other regions, including in Europe. Their purpose is to...