Safety Risk Management: A Focus on EU RMPs and US REMS

Register for this On-demand Training Course to learn about benefit-risk assessment methods and how to incorporate the patient perspective.

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.

Everything you need to know to effectively write safety reports.

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

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 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.