Introduction and Enlightments of ICH E2C(R2) Periodic Benefit-Risk Evaluation Reporting

Abstract

Abstract: Due to the complexity of targeted population and environment, new safety and efficacy problems of post-marketing drugs may be found differrent from the Conclusion s of clinical trials, while the PBRER is an important pharmacovigilance tool. It can be a means of determining changes in the benefit-risk profile and an indicator for the need of risk management initiatives. This paper introduced the content of the new Periodic Benefit-Risk Evaluation Reporting, aiming to understand the new concepts and principles of PBRER, and provide reference for related work in our country in the future.

Key words: PSUR, PBRER, signal, risk assessment

CLC Number:

R954

YUAN Li ,YANG Yue. Introduction and Enlightments of ICH E2C(R2) Periodic Benefit-Risk Evaluation Reporting [J]. Chinese Journal of Pharmacovigilance, 2013, 10(11): 650-654.

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URL: https://zgywjj.magtechjournal.com/EN/

https://zgywjj.magtechjournal.com/EN/Y2013/V10/I11/650

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Introduction and Enlightments of ICH E2C(R2) Periodic Benefit-Risk Evaluation Reporting

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