• 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:

• Discuss the key concepts, principles, and tools used in risk management and risk minimization
• Apply 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
• Explain the post-marketing commitments for a REMS and EU-RMP
• Describe the process for developing a global risk management strategy and customization based on local and regional variations