A Practical Guide to Writing Risk Management Plans (RMPs)

Understand RMPs relationship to safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance

28 Jan 2019

& 2 Jul 2019

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 21 Dec

Book now

Course Overview

In the EU, all companies are required to provide Risk Management Plans (RMPs) for every new product, whether generic products or new chemical entities, and these RMPs must also be modified and updated throughout the lifetime of a medicine. This course will provide an invaluable overview on writing and maintaining Risk Management Plans, with practical advice to ensure you achieve regulatory compliance. This course has been fully revised to include the latest updates.

By attending this course you will:

  • Gain an overview of ICH and EU RMPs – their production and maintenance
  • Clarify the documentation to be supplied to regulators and the process for RMPs
  • Discuss the EU Templates and their completion – generic and innovator products
  • Understand the relationship with PSMFs to safety reviews; PBRERs/DSURs and licence submissions

Please note that we are also running:

Book together and save

This meeting runs back-to-back with Producing and Maintaining the Pharmacovigilance System Master File (PSMF) on 3 July 2019. Save an additional £100/€140 if you book both together.

To find out more please call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Who should attend

This course will be relevant for those working in pharmacovigilance who are involved with writing Risk Management Plans, including Medical Directors/QPPVs who approve such plans. It will also be of interest to those who work with pharmacovigilance, eg in regulatory affairs, clinical, sales and marketing, legal, commercial and quality.

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 30 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.

Book now

28 Jan 2019
28 Jan 2019 Cavendish Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 21 Dec
Enrol now
2 Jul 2019
2 Jul 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Alfa Wassermann S.p.A.
  • A Nelson & Co Ltd
  • Alfrapharma Srl
  • ALLERGAN FRANCE S.A.S.
  • Colgate-Palmolive R&D
  • Conforma NV
  • DBV Technologies
  • ELPEN Pharmaceutical Co Inc
  • Emtex BVBA
  • Ewopharma International s.r.o
  • FAES FARMA SA
  • Ferrer Internacional, S.A.
  • Iggea Ltd
  • Jacobsen Pharma & MedTech Advice A/S
  • Janssen Pharmaceutica NV
  • Jenson R+ Ltd
  • Kem Pharmaceuticals Limited
  • Kyowa Kirin Services Ltd
  • Mapi Life Sciences Canada Inc.
  • Medac GmbH
  • Mediplex Ltd
  • Norgine Ltd.
  • Pharmacovigilance Matters Limited
  • ProductLife
  • Recordati
  • Red Line Pharmacovigilance
  • Roche Products Ltd - WELWYN GARDEN CITY, Hertfordshire
  • VAN Pharma Consult
  • Veterinary Medicines Directorate
  • Wockhardt UK Ltd

Very knowledgable about [the] subject area. Good content and interesting presentation and speaker.

Harriet Gillespie, Senior Medical Writing Scientist, Janssen-Cilag Limited

Very knowledgeable. Very well presented and in-depth description presented on each section.

Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International

I enjoyed Graemes real world examples. He addresses people with different knowledge abilities very well

Alice King, Regulatory Affairs Associate, Creo Pharma Ltd

Good course, would recommend it to others as well. Speakers well prepared and the presentation was good.

Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd

Overall a well organized course providing relevant knowledge about preparing RMPs. The presentation was good and the presenter has a substantial experience in the field of PV.

Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd

Fantastic

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies

Very useful and engaging

Lauren Tuitt, , ProductLife

Good course, good topic. Practical details offered, experiences. The speaker is excellent with the topic and has great experience.

Jorge Ignacio Gonzalez Borroto, Pharmacovigilance Officer, Grupo Ferrer Internacional SA

I have always found Management Forum courses to be of a high standard. They are my preferred teaching and training source for staff at Redline PV

Shirley-Ann Van Der Spuy, EU QPPV, Redline Pharmacovigilance Ltd