A Practical Guide to Writing Risk Management Plans (RMPs)

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

27 Jan 2020

& 29 Jun 2020

GBP 699
EUR 979
USD 1,090

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 of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. The programme 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 between RMPs and safety reviews; PBRERs/DSURs; 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). 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 RMPs, 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

An introduction to EU RMPs – production and maintenance

  • ICH E2E
  • EU Module V
  • 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 and their completion – generic and innovator products including RMPs in other countries

  • The EU generic template – EU requirements
  • The EU template for innovator products

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, section VII

  • Annex 1: Interface between RMP and EudraVigilance/EPITT
  • Annex 2: Tabulated summary of planned, ongoing and completed pharmacovigilance study programme
  • Annex 3: Protocols for proposed, ongoing and completed studies in the pharmacovigilance plan
  • Annex 3 part A: Requested protocols of studies in the pharmacovigilance plan
  • Annex 3 part B: Requested amendments of previously approved protocols of studies in the pharmacovigilance plan
  • Annex 3 part C: Previously agreed protocols for ongoing studies and final protocols not reviewed by the competent authority
  • Annex 4: Specific adverse event follow-up forms
  • Annex 5: Protocols for proposed and ongoing studies in RMP part IV
  • Annex 6: Details of proposed additional risk minimisation activities
  • Annex 7: Other supporting data (including referenced material)
  • Annex 8: Summary of changes to the risk management plan over time

Book now

27 Jan 2020
27 Jan 2020 Venue not yet confirmed GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
29 Jun 2020
29 Jun 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Alfrapharma Srl
  • Blue Reg Europe
  • Chiesi Farmaceutici S.p.a.
  • Colgate-Palmolive R&D
  • Conforma NV
  • Creo Pharma Ltd
  • Dermal Laboratories Ltd
  • Faes Farma
  • FAES FARMA SA
  • Ferrer Internacional, S.A.
  • Griffiths Medical Writing Ltd
  • Icon Clinical Research (UK) Limited
  • Iggea Ltd
  • INNATE PHARMA
  • IRE-TEX INNOVATIONS LTD
  • JensonR+ Ltd
  • Kyowa Kirin Services Ltd
  • Mapi Life Sciences Canada Inc.
  • Norgine Ltd.
  • ProductLife
  • Recordati
  • Red Line Pharmacovigilance
  • Research and Markets
  • Roche Products Ltd
  • Roche Products Ltd - WELWYN GARDEN CITY, Hertfordshire
  • Rosemont Pharmaceuticals Ltd
  • Sanquin Plasma Products
  • VAN Pharma Consult
  • Wockhardt UK Ltd
  • ZAMBON SPA

The course was fast paced, but if we had questions Graeme went back over and clarified, which I appreciated as I didn't share the same background as most of the other course candidates. I walk away with a clear understanding of the guidance behind and purpose of Risk Management Plans

Jennifer Hynes, Quality Manager, Benchmark Vaccines Limited

Overall, I'm satisfied with the course and i think the sequence of the course topics was very logical and organised although it was condensed.

Rania Ali, Senior Safety Associate, Amgen

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

Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International

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

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

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

Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd

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

Alice King, Regulatory Affairs Associate, Creo Pharma 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

Very useful and engaging

Lauren Tuitt, , ProductLife

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

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

Fantastic

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies