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Risk Management Plans

 
National Institutes of Health

Papers overview

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2017
2017
Historically, global drug safety regulations were generally reactive and post-marketing safety monitoring comprised mainly… Expand
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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… Expand
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2014
2014
Background Fingolimod is a once-daily oral treatment for relapsing multiple sclerosis, the proprietary production processes of… Expand
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Review
2013
Review
2013
BackgroundRisk management plans (RMPs) describe known and potential safety concerns with medicines, how they will be studied… Expand
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2012
2012
A medicinal product is authorized on the basis that in the specified indication(s), at the time of authorization, the benefit… Expand
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2012
2012
The authors conducted an assessment of pharmacovigilance (PV) strategies on behalf of the Product Development Partnership (PDP… Expand
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2011
2011
Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of… Expand
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2008
2008
PURPOSE Following the adoption of the ICH E2E guideline, risk management plans (RMP) defining the cumulative safety experience… Expand
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2006
2006
In November 2005, the European Medicines Agency, the EMEA, published its guidelines on risk management plans (RMPs). Just under a… Expand
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Review
2006
Review
2006
  • Rosie Stather
  • International Journal of Pharmaceutical Medicine
  • 2006
  • Corpus ID: 23018140
In November 2005, the European Medicines Agency (EMEA) published its guideline on risk management plans (RMPs).1 Just under a… Expand
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