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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[1]
Type Public / Private

Services

  • 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

Top 5 Recent Tweets

DateAuthorComment
April 07, 2023PNS_NCFayetteville Center Calls for Vigilance in Reporting Child Abuse https://t.co/n5MwGkKkxo https://t.co/2InX6xf0cw
April 07, 2023PNS_NCFayetteville Center Calls for Vigilance in Reporting Child Abuse https://t.co/n5MwGkKkxo https://t.co/Dt2s8T5SoC


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