NC Vigilance

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NC Vigilance is a specialist consultancy offering a range of pharmacovigilance services. With the introduction of the new EU Pharmacovigilance legislative in 2012, more focus is given on the assessment of the benefit/risk ratio of the drugs as well as on the risk management.

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Type Public / Private


  • Medical writing, including:

- Drug safety profiles - Aggregate reports: Addendum to Clinical Overview, Periodic Benefit Risk Evaluation Reports, Periodic Annual Drug Evaluation Reports - Risk Management Plans and education tools - Responses to ad hoc regulatory requests

  • Signal detection, validation and evaluation
  • Development of risk minimization measures and communication plans towards healthcare providers
  • Literature screening
  • Quality review of individual case reports
  • Development and update of standard operating procedures and working manuals
  • Translation of SPCs from/to English and East European languages

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March 29, 2023Jpk74085345Jpk@DC_Draino That’s what we did in NC. Vigilance and a willingness to strengthen defense, and legally procure weapons…

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