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25/04/2017
“The Benelux Pharmacovigilance Day 2016”.

Come and join us at “The Benelux Pharmacovigilance Day 2016” on October 11, 2016, in Amsterdam....

25/04/2017
"Risk minimization in data anonymization process"

Come and join us in Barcelona for the 2016 PhUse annual conference. ...

25/04/2017
KeyrusBiopharma is going to be present on the “BCF Career Event Belgium”.

KeyrusBiopharma is going to be present on the “BCF Career Event Belgium”....

25/04/2017
DII 3rd annual conference on

DII 3rd annual conference on "Health data revolution"...

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Our Know-How

Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse events (AE) and other medicine­related problems resulting from the use of drugs or products intended for human use either during clinical trials or after their marketing authorization.

Thanks to extensive knowledge of the regulations and the Good PV Practices, our Clinical Safety and PV Coordinators, Scientists and Physicians manage the following activities:

 

Case Processing

  • Data entry into Client’s database or in our own database Argus Safety
  •  Coding according to MedDRA and to other dictionaries
  •  Quality control
  •  Medical review, causality and expectedness assessment
  •  Expedited reporting to CA
  • Off-Shore case processing team also available

Safety Aggregate Report Writing

  • Writing and peer review experience in several therapeutic areas:
    •  Oncology
    •  Vaccinology
    •  Immunology
    •  CNS
    •  Internal Medicine

Literature Screening

  • Search in Medical and Scientific databases,
  • Screen and medical review of  the collected references in order to identify AE or other relevant safety information
  • AE reporting
Signal Detection and Benefit Risk Assessment
  • Extract information from all sources of safety
  • Generate list of signals
  •  Prioritize the signals
  •  Evaluate the benefit/risk balance of the drug
  •  Initiate further actions (RMP update, label change…)

Product Complaint Management

QPPV Services

Medical Coverage Hot line 24/7

  • +32 2 386 01 80
  • +32 2 627 51 35
  • BE.drugsafety@keyrus.be

 

Your Key Service Provider for Safety Tasks