Risk Management Principles for Devices and Pharmaceuticals

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Risk Management Principles for Devices and Pharmaceuticals

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This second edition includes expanded and updated risk management information on healthcare products around the world. Before a biologic, pharmaceutical or medical device product can be approved and marketed, and throughout its lifecycle, the manufacturer must prove that any risk(s) associated with its use has been reduced as far as possible. This book includes information on, among other things:

  • preclinical, clinical and postmarketing risk evaluation
  • regional risk management requirements
  • benefit-risk assessment
  • pregnancy registry use
  • quality risk management
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