EudraVigilance Services

AXPHARMA has anticipated the regulatory changes related to EudraVigilance and can offer you its services now. Contact us to help you comply with this new regulation.

axpharma-audits

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

 

  • Vigilance Systems Services

AXPHARMA Vigilance Systems Services includes, but are not limited to:

  • Project Management
  • Safety database consultancy
  • E2B (R3) system implementation
  • Database validation tasks (Validation Master Plan, Risk Analysis, Test Plan, Protocols, Validation Summary Report)
  • Legacy data migration (consulting services and validation)
  • Database administration and maintenance