Advanced Signal Management - Detection, Evaluation, and Decision-Making

Learn the principles of safety sciences including toxicology, clinical pharmacology, pharmacogenomics, and pharmacoepidemiology in order to analyze potential safety issues.

Learn more about pharmacovigilance harmonization initiatives and regulatory requirements in the US and EU.

Develop a foundation of knowledge required to work day-to-day in clinical safety and pharmacovigilance.

Learn about safety monitoring requirements for drugs after they are approved for marketing.

Learn the framework and details around drug safety requirements for clinical trials for drugs in humans.

Learn how labeling is developed and maintained throughout the product’s marketed life, and the components and structure of prescription labeling.

This online course provides information on planning a business outsourcing model, best practices for selecting and managing providers, and regulatory authority expectations for pharmacovigilance agreements.