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Event Details


A Practical Guide to Writing Risk Management Plans (RMPS)

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Who should attend?

This course will be relevant for anyone requiring a comprehensive overview of the pharmacovigilance function and duties and may be of particular interest to those who are responsible in pharmacovigilance for any safety assessments and writing such plans including any medical directors who approve such plans. those who work with pharmacovigilance, e.g. regulatory affairs, clinical, sales and marketing, legal, commercial and quality and EU QP PVs that must sign off such documents.


Course Overview

The pharmacovigilance legislation of 2012 requires companies to provide Risk Management Plans (RMPs) and assessments for all new products, whether generic products or new chemical entities. If these are not done correctly this can delay both licensure and sales and damage the company’s ability to maximise its products. Maintenance of RMPs is also an important aspect of maintaining compliance.

Topics to be covered will include:

  • An Introduction to ICH & EU RMPs – Production & Maintenance
  • Documentation to be Supplied to Regulatory Authorities – the process for RMPs
  • The EU Templates & their Completion – Generic and Innovator Products
  • RMPs in other Countries
  • Practical – Completion of Sections I – III
  • Practical – Completion of Sections IV – VI
  • Practical – Completion of Annexes




Leigh White

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