Pharmacovigilance System Compliance During Medical Product Life Cycle - ECCRT
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Pharmacovigilance System Compliance During Medical Product Life Cycle

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Pharmacovigilance system compliance training - ECCRT

About this course

Reasons to attend

The course will highlight the mandatory requirements for pharmacovigilance system compliance during medicines products life cycle indicating the main pillars for compliance effectiveness and the relevant key operational processes.
The course is composed of 2 parts: day one is providing the essential elements in pharmacovigilance, whereas day two consists of practical workshops for the attendees with pharmacovigilance functions. Day one can be attended as a standalone course.

What's included?

  • Documents and materials related to this course are included
  • Globally recognised certificates awarded after test completion
  • This course has been granted PharmaTrain Recognition

Course schedule

  • Two Day face-to-face training: 09h00-17h00

  • Course Description

    Day 1: Essentials for pharmacovigilance compliance
    Morning session:
    • Pharmacovigilance Systems and sponsors & MAHs responsibilities
    • PV System Quality Management
    Afternoon session:
    • Regulatory Intelligence
    • Business Continuity Plan
    • Contractual Agreements
    Day 2: “Advanced course” Pharmacovigilance Business Operations – Key operational Processes
    Morning session:
    • Essential / Basic Business Operation processes
    • PV Tools - EMA go life plan
    • Safety Monitoring
    • Workshop
    Afternoon session:
    • Signal Management cycle and Risk minimisation strategy
    • Inspection readiness
    • Workshop
    • Q&A - training Closure

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