EudraVigilance Services

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AXPHARMA a anticipé les évolutions réglementaires liées à EudraVigilance et peut vous proposer dès à présent ses services. Contactez-nous pour vous accompagner pour la mise en conformité à cette nouvelle réglementation.

AXPHARMA EudraVigilance Services includes, but are not limited to:

  • Change management & communication plan
  • Registration with EudraVigilance for pharmaceutical companies
  • Provision of Responsible Person (& ‘Trusted’ Deputy)
  • Arrangement of QPPV EV services
  • Registration of individual users (‘HQ’/Third party service provider/Affiliate level)
  • Registration & testing with National Competent Authorities
  • EV training plan & kits (PPT, Video, Quiz)
  • Case management of suspected adverse reactions, including contact with reporters, MedDRA coding, Data Entry and Electronic reporting to EMA via EVWEB
  • Introduction of information of medicinal products in XEVMPD
  • Medical Literature searches for Pharmacovigilance including MLM services
  • Signal detection via EVDAS tool starting on November 22nd, 2017
  • Review of internal registration documentation
  • Maintenance of EV registrations (staff movements, changes in legislation etc.)
  • Review of EudraVigilance-related pharmacovigilance documentation
  • EV testing and legacy data transfer (E2B standards)
  • End user Training pharmacovigilance and GVP

Lorem Ipsum Dolor

Nunc et vestibulum velit. Suspendisse euismod eros vel urna bibendum gravida. Phasellus et metus nec dui ornare molestie. In consequat urna sed tincidunt euismod. Praesent non pharetra arcu, at tincidunt sapien. Nullam lobortis ultricies bibendum. Duis elit leo, porta vel nisl in, ullamcorper scelerisque velit. Fusce volutpat purus dolor, vel pulvinar dui porttitor sed. Phasellus ac odio eu quam varius elementum sit amet euismod justo.

Lorem Ipsum Dolor

Nunc et vestibulum velit. Suspendisse euismod eros vel urna bibendum gravida. Phasellus et metus nec dui ornare molestie. In consequat urna sed tincidunt euismod. Praesent non pharetra arcu, at tincidunt sapien. Nullam lobortis ultricies bibendum. Duis elit leo, porta vel nisl in, ullamcorper scelerisque velit. Fusce volutpat purus dolor, vel pulvinar dui porttitor sed. Phasellus ac odio eu quam varius elementum sit amet euismod justo.

Lorem Ipsum Dolor

Nunc et vestibulum velit. Suspendisse euismod eros vel urna bibendum gravida. Phasellus et metus nec dui ornare molestie. In consequat urna sed tincidunt euismod. Praesent non pharetra arcu, at tincidunt sapien. Nullam lobortis ultricies bibendum. Duis elit leo, porta vel nisl in, ullamcorper scelerisque velit. Fusce volutpat purus dolor, vel pulvinar dui porttitor sed. Phasellus ac odio eu quam varius elementum sit amet euismod justo.

Lorem Ipsum Dolor

Nunc et vestibulum velit. Suspendisse euismod eros vel urna bibendum gravida. Phasellus et metus nec dui ornare molestie. In consequat urna sed tincidunt euismod. Praesent non pharetra arcu, at tincidunt sapien. Nullam lobortis ultricies bibendum. Duis elit leo, porta vel nisl in, ullamcorper scelerisque velit. Fusce volutpat purus dolor, vel pulvinar dui porttitor sed. Phasellus ac odio eu quam varius elementum sit amet euismod justo.

Lorem Ipsum Dolor

Nunc et vestibulum velit. Suspendisse euismod eros vel urna bibendum gravida. Phasellus et metus nec dui ornare molestie. In consequat urna sed tincidunt euismod. Praesent non pharetra arcu, at tincidunt sapien. Nullam lobortis ultricies bibendum. Duis elit leo, porta vel nisl in, ullamcorper scelerisque velit. Fusce volutpat purus dolor, vel pulvinar dui porttitor sed. Phasellus ac odio eu quam varius elementum sit amet euismod justo.