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

Develop the foundational knowledge required to work day-to-day in clinical safety and pharmacovigilance.

Increase your understanding about safety monitoring requirements for drugs after they are approved for marketing.

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

Explore the basic concepts of safety signal detection, data mining, and the context for interpreting signaling results.

Explore the basics of drug safety and safety sciences in this seven module eLearning bundle.

Expand your knowledge about drug safety throughout the medical product development lifecycle from regulations and requirements to pre-market review and post-market monitoring in this six module program.

Learn about safety audits and inspections with a focus on FDA, EMA, MHRA, and Health Canada inspections.

Complete thirteen of the core learning track courses for the Safety and Pharmacovigilance Certificate Program with this online package.

Review how to design, develop, and manage a quality system related to your pharmacovigilance system to achieve quality and regulatory compliance.

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.

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

Review the key benefits-risk assessment methods and how to incorporate the patient perspective.