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Signal Management and Its Role as a Critical Component of Pharmacovigilance

Mitchell Gandelman

Introduction Signal management is one of the most crucial steps in pharmacovigilance and is defined in numerous guidelines to various degrees (EMA Guideline on Good Pharmacovigilance Practices (GPV) Module IX – Signal Management1, FDA Guidance for Industry, Good Pharmacovigilance Practices and Pharmacoepidemiology...

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David Balderson, Vice President of Global Safety Operations

What is ICSR Quality and How Is It Measured?

David Balderson

In my experience of being in the operational side of Safety for the last 16 years, I have learned that the perception of what ICSR (Individual Case Safety Reports) quality means often varies between the company’s perspective as an MAH (Marketing Authorization...

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