A discussion we have again and again inseminars is the question of planned deviations. To make it short: in GMP, nothing should be declared as a de ...
Since data integrity has become a "hot topic" in the pharmaceutical industry, ALCOA+ has been cited as the ultimate reference. Nevertheless, the me ...
The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigat ...