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

This On-Demand Training course is focused on the strategic and operational aspects of global safety risk management. Key concepts, principles, and tools necessary to develop risk management programs will be introduced. Participants will be exposed to the regulatory requirements in the US and European Economic Areas (EEA). Through interactive case studies, learners will engage in exercises to apply the knowledge gained from instructional sessions.

This on-demand training course takes an average of 8 hours to complete. Learners have access to the course for one year from the date of purchase.

• Guidelines and regulations for RMPs and REMS
• Core elements of an EU-RMP and REMS, and associated templates
• Terminology used in risk management programs
• Safety risk management processes, including roles and responsibilities of risk management colleagues
• Strategic and operational aspects of safety risk management programs

This program is designed for professionals involved in:

• Risk management planning; development of RMPs (Risk Management Plans) and REMS (Risk
• Evaluation and Mitigation Strategies)
• Drug safety and pharmacovigilance (PV)
• Benefit-Risk assessment
• Risk communication
• Pharmacoepidemiology
• Medical writing
• Regulatory affairs, regulatory strategy
• Medical affairs, medical information/communication
• Pharmacovigilance quality management
• Other disciplines that interact with or support safety and PV functions across the product lifecycle

At the conclusion of this course, participants should be able to:

• Identify the key concepts, principles, and tools used in risk management and risk minimization
• Evaluate the current guidelines and regulations for risk management in key markets, including the EEA and US
• Compare and contrast the EU-RMP with the US REMS and identify core elements common to both
• Identify the post-marketing commitments for a REMS and EU-RMP
• Analyze the process for developing a global risk management strategy and customization based on local and regional variations