The requirements for Pharmacovigilance in the United States as compared to the ones in the European Union, for Pre-approval and Post-approval and the imminent changes in the European Union and in the United States
regulations, comparison, USA, EU, legislation, guidelines, pharmacovigilance
LEARNING OUTCOMES
At the end of the course, you will have a conceptual understanding of pharmacovigilance regulations and guidelines in the US as related to EU legislation and guidance.