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Sep 24, 2018 8:15 AM - Dec 31, 2050 3:00 PM

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


This 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.

What you will learn

  • 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

Who should attend?

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

Learning objectives

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


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