Join us and celebrate the 20 years anniversary of ECA in Heidelberg at the 8th European GMP Conference - Meet speakers from US FDA, EU GMP Inspectorates and Pharmaceutical Industry to hear the latest GMP Trends - Receive the latest ECA Guidance Documents at no costs!
From 9-10 April 2019 in Düsseldorf, Germany - More than 60 Speakers from pharmaceutical companies and GMP Inspectorates - Case Studies from Novartis, Roche, Boehringer Ingelheim, Sanofi, Bayer, Pfizer and many more - 3 GMP/FDA Conferences – create your own agenda!
With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.
In response to the increasing need for a guidance paper for radiopharmaceuticals in non-clinical settings, the EMA has published a "Draft guideline on the non-clinical requirements for radiopharmaceuticals".
In January, the FDA published a guide on immune responses to protein products: "Immunogenicity testing of therapeutic protein products - Development and validation of assays for the detection of antidrug antibodies".