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17 Dec 2015

A Practical Guide to Writing Risk Management Plans

Research and Markets has announced the addition of the "A Practical Guide to Writing Risk Management Plans (RMPS) (London, UK — 25 January 2016)" conference to their offering.

The new Pharmacovigilance Legislation of 2012 now requires companies to provide Risk Management Plans (RMPs) and assessments for all new products whether those products are generic products or new chemical entities.

If these are not done correctly this can delay both licensure and sales and damage the company ability to maximise its products. Maintenance of the RMPs also is an important aspect for maintaining the licence, compliance and these are reviewed in Regulatory Inspections. Can you afford not to get this right?

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 Annexe
  • Related News