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

Learn the strategic and operational aspects of global risk management. The course will cover key concepts, principles, and tools necessary to develop risk management programs.

Overview

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.

Can't attend this course? Join us in 2020: Philadelphia in October!

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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