by Ursula Tschorn | Jul 30, 2018
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 | Aug 6, 2015
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 | Jul 17, 2015
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 13, 2015
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
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...
