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A Practical Guide to Writing Risk Management Plans (RMPS): 1-Day Course (London, United Kingdom - July 2, 2019) -

The "A Practical Guide to Writing Risk Management Plans (RMPS)" conference has been added to's 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 Annexes

Speaker: Graeme Ladds, Director, PharSafer Associates Ltd.

Graeme Ladds has over 22 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

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Last Updated: 04-Dec-2018