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...