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 | 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 | May 22, 2015 | Abbreviations, IDMP Solutions
Master Data Management (MDM) is critical for IDMP compliance In matching IDMP´s required data with customer´s data there will be several systems identified which hold IDMP relevant data. In case of Marketing Authorisation Holders (MAHs) this will be...
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...
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...