Benefit-Risk Assessment and Management Across the Lifecycle

In this on-demand training course, learn how to enhance the effectiveness of safety risk communication in light of evolving regulatory expectations.

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

Learn about basics of drug safety and safety sciences in this seven module eLearning bundle.

Learn 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.

Register for this On-demand Training Course to learn the strategic and operational aspects of global risk management. The on-demand course will cover key concepts, principles, and tools necessary to develop risk management programs.

Register for this On-demand Training Course and learn how to design, develop, and manage a quality system related to your pharmacovigilance system.

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.