Events

Advanced Pharmacovigilance Skills

  • Wed 09 May 2018
  • All Day

Date of next meeting: 9th May 2018
Venue: Legoland Conference Centre, Windsor
Cost: £350 + VAT

Running for its second year, this interactive course will cover the following subjects:

  • An overview of the key critical PV processes, including:
    • Interactions with PV and Product Quality
    • Responding to Authority Requests
    • Business continuity in PV.
  • An overview of effective management of a variety of PV system data and documentation, including:
    • Records management
    • Documentation of the Quality System
    • PV agreements.
  • An interactive session reviewing strategies for managing special interest cases and policies on conducting follow-up investigation for:
    • Medication errors
    • Off-label use
    • Lack of efficacy
    • Overdose / misuse / extravasation
    • Pregnancy / breast feeding / occupational exposure
    • Product issues.
  • An overview of risk management plans and risk minimisation, including:
    • A review of GVP Modules V and XVI
    • A discussion on the writing of the RMP and subsequent management of updates and regulatory submissions.
  • An overview of signal detection and safety communication, including looking at GVP Module IX and various techniques for conducting signal detection. This session will also discuss when and how to communicate safety issues.
  • An interactive workshop on how companies manage signal detection and risk management activities and any subsequent actions that arise from them.
  • A look at key performance indices / metrics and how companies manage metrics to include case processing and major submissions.

 Target audience:

Pharmacovigilance managers and PV professionals with a number of years of experience.

 

 

Time: 1 day face to face course

 

 
Level of difficulty: Intermediate / Advanced

 

 

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