by Ursula Tschorn | May 22, 2015
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 Regulatory...
by Ursula Tschorn | Jul 13, 2015
Medical Dictionary for Regulatory Activities (MedDRA)
by Ursula Tschorn | Mar 20, 2017
The National Competent Authorities (NCAs) are the national agencies for the evaluation of medicinal products
by Ursula Tschorn | Sep 15, 2016
OMS is short for Organisations Management Services (OMS)
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...
