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DIA Global Center

2018 年 09 月 24 日 8:15 上午 - 2018 年 09 月 25 日 3:00 下午

21 Dupont Circle NW, Suite 300, Washington, DC 20036

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

Session 7: Content of an EU Risk Management Plan (EU-RMP)

Session Chair(s)

Carla  Barrett, PHARMD

Carla Barrett, PHARMD

Vice President, Global Risk Management

Novavax, United States

    This session will review the requirements for an EU-RMP based on GVP Module V Risk Management Systems and GVP Module XVI Risk Minimization Measures: Selection of Tools and Effectiveness Indicators.

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