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26/09/2017
“The new biosimilar market” / « Le nouveau marché des biosimilaires » - The 7th annual conference of DII.

“The new biosimilar market” / « Le nouveau marché des biosimilaires » - The 7th annual confer...

26/09/2017
Afcros - “Clinical Research Day”.

Afcros - “Clinical Research Day” - January 26,2017...

26/09/2017
[Conference] Meet Keyrus Biopharma at the "IFB eHealth Day 2017: patient health data in policy and research"

[Conference] Meet Keyrus Biopharma at the "IFB eHealth Day 2017: patient health data in pol...

26/09/2017
[Conference] Keyrus Biopharma will be participating in “Pharmaceutical Contract management group – 2017 Conference”

[Conference] Keyrus Biopharma will be participating in “Pharmaceutical Contract management group ...

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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