In June 2018 EU authorities were notified about the presence of N-nitrosodimethylamine in Valsartan batches of a Chinese API manufacturer. Since then more and more cases of drug substance and drug product batches contaminated with Nitrosamines came to be known. Now all Marketing Authorization Holders are obligated to evaluate the risks of their products containing chemically synthesized APIs within a very short deadline.
To help you find out how you efficiently perform the requested risks assessments, the ECA together with APIC/CEFIC and the European QP Association have organized a 1-Day Urgent Compliance Meeting "Nitrosamine Impurities" on 18 February 2020 in Frankfurt. In addition you will learn there,
During this meeting you will also benefit from tools and aids you will receive - like decision trees or templates for risk assessments.