Risk Management Plans

 
National Institutes of Health

Topic mentions per year

Topic mentions per year

2003-2017
012320032017

Papers overview

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2017
2017
Historically, global drug safety regulations were generally reactive and post-marketing safety monitoring comprised mainly… (More)
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2014
2014
Risk Management Plans (RMPs) have become a cornerstone in the pharmacovigilance of new drugs in Europe. The RMP was introduced in… (More)
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2014
2014
BACKGROUND Fingolimod is a once-daily oral treatment for relapsing multiple sclerosis, the proprietary production processes of… (More)
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Review
2013
Review
2013
Risk management plans (RMPs) describe known and potential safety concerns with medicines, how they will be studied further and… (More)
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Review
2012
Review
2012
  • Rosie Stather
  • International Journal of Pharmaceutical Medicine
  • 2012
In November 2005, the European Medicines Agency (EMEA) published its guideline on risk management plans (RMPs).1 Just under a… (More)
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2011
2011
Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of… (More)
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2011
2011
Garattini and Bertele' [1] ask “Anything new in EU pharmacovigilance”? This is a rhetorical question – they expected some new… (More)
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2008
2008
PURPOSE Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience… (More)
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Review
2003
Review
2003
The prospect of industrial accidents motivated the U.S. Congress to require in the Clean Air Act of 1990 that manufacturing… (More)
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2003
2003
The Environmental Protection Agency has proposed regulations that outline risk management program guidelines. The intent of these… (More)
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