A Practical Guide to Writing Risk Management Plans (RMPS)

29 Jan 2018

	GBP	EUR	USD
Standard	699	979	1090
Early	599	839	934
Excluding VAT @ 20.00%

Book by 15 Dec to get the early booking price shown above.

Venue: Rembrandt Hotel, London

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4 Jul 2018

	GBP	EUR	USD
Standard	699	979	1090
Excluding VAT @ 20.00%

Venue not yet confirmed

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Bespoke training

We can customise this course to meet the requirements of your organisation.

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Course Overview

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

Why you should attend

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?

Who should attend

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.

Programme

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

Presenter

Graeme Ladds

Graeme Ladds, Director of PharSafer, has over 26 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he 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.