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03-Jul-2019 - 03-Jul-2019

A Practical Guide to Writing Risk Management Plans (RMPS)

  • Location:
    • Thurloe Place
    • London
    • Greater London
    • SW7 2RS
    • United Kingdom
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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