Home / Safety / Operations

Operations:

Set up and Management of Customized Operations

  • Case management in Clinical Trials, SAE/SUSAR
  • Case management in Post-marketing ADR
  • Medical review and medical writing
    • Periodic safety reports : PSUR, DSUR
    • Experts opinion
    • Ad hoc safety reports
    • safety in Investigational brochures
    • Answers to Authorities queries
  • Medical Information
  • Regulatory Survey
  • Literature Survey

IT Tools:

  • Customized Safety data-base
    • Web based
    • E2B & 21CFR part11 compliant
    • Editing XLM format
    • Export and import of data from any compliant data base
    • Electronic reporting
  • Call centre
    • 24/7/365
    • Multilingual
    • Staff qualified in PV and Medical Information
    • High traceability

Electronic reporting :

  • Eudravigilance
    • Registration of company, users, study, in EVPM (Post marketing) and in EVCT (Clinical Trial)
    • database validation tests
    • registration of products in EVMPD (Medical Products Dictionary)
    • registration of Risk Management Plan
  • Other Authorities
    • registration in all European National Competent Authorities
    • registration in US FDA

Training:

by accomplished speakers with long practice in teaching*

  • Set up of the Training Plan (part of the PV system master file)
  • Commercialization of e-training
  • For beginners or confirmed professionals
  • Hands on with cases studies
  • Topics:
  • Regulation & processes in Pharmacovigilance
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  • Quality Assurance in Pharmacovigilance
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  • Risk management
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  • Immuno-pharmacovigilance
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  • Signal detection
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  • Advanced Therapy
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  • Comparing US-EU regulation
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  • Medical device safety
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  • Crisis management
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  • Risk communication
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  • Eudravigilance, e-reporting, MedDRA queries
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  • Cosmetics safety
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    Lecturers : Pool of ISOP lecturers, Faculty of Pharmacy, DIA, IFIS, EFE…