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Current Status of Post-marketing Safety Management in United States, Europe and Japan: Risk Management Plan

Kim SH, Kim HJ, Choi NK

  • KMID: 2534637
  • .
  • 2020 Sep;12(2):70-78.
Since the limitations of pre-marketing clinical trials, "whole life-cycle managements" that confirm the safety and effectiveness of drugs from the development stage to the post-marketing stage is being emphasized. The...
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Contributors to Fatigue of MineWorkers in the South African Gold and Platinum Sector

Pelders J, Nelson G

BACKGROUND: Mine workers in South Africa face challenges relating to poor health and safety, including fatigue risks, and poor socioeconomic and living conditions. Fatigue results in impaired mental and physical...
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Risk management and principal features of REMS

Lee JH

A safe drug is defined as one for which the benefit of the medication is greater than the expected risk, taking all factors into account. To enhance the safety of...
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