A Practical Guide to Writing Risk Management Plans (RMPS)

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

Please note that we are also running:

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?

This course will be relevant for anyone requiring a comprehensive overview of the Pharmacovigilance function and duties. It 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 & Marketing, Legal, Commercial and Quality and EU QP PVs that must sign off such documents.

09.00 Registration and Coffee

09.30 Meeting begins

An Introduction to EU RMPs – Production & Maintenance

• ICH E2E – Risk Management Plans
• EU Module V – Risk Management Plans
• Production of the EU RMP
• Maintenance of the RMP (Safety Reviews; PSURs/DSURs)

Documentation to be Supplied to Regulatory Authorities – the process for RMPs

• Generic RMPs
• RMPs for Innovator products
• Additional documents to supply to the Regulators
• Safety reporting Timelines for RMPs
• Japan and the USA and RMPs

The EU Templates & their Completion – Generic and Innovator Products Including RMPs in other Countries

• The EU Generic template
• The EU Template for innovator products
• The RMP Template in Japan

Practical – Completion of Sections I – III

• Section I – Information sources and completion
• Section II – Common aspects for Risk appraisal from Clinical Studies
• Section III – The Pharmacovigilance Plan

Practical – Completion of Sections IV – VI

• Section IV – Post Authorisation Efficacy Studies
• Section V – Risk Minimisation Activities
• Section VI – Summary of the RMP

Practical – Completion of Annexes

• Annex 1: Interface between RMP and Eudravigilance/EPITT
• Annex 2: Summary of product characteristics (SmPC) and package leaflet.
• Annex 3: Worldwide marketing authorisation status by country (including EEA)
• Annex 4: Synopsis of on-going and completed clinical trial programme
• Annex 5: Synopsis of on-going and completed pharmacoepidemiological study programme
• Annex 6: Protocols for proposed and on-going studies
• Annex 7: Specific adverse event follow-up forms
• Annex 8: Protocols for proposed and on-going studies in RMP part IV
• Annex 9: Synopsis of newly available study reports for RMP parts III-IV
• Annex 10: Details of proposed additional risk minimisation activities (if applicable)
• Annex 11: Mock up examples of the material provided to healthcare professionals and patients
• Annex 12: Other supporting data (including referenced material)

17.00 Meeting ends