Presented by
Management Forum

A Practical Guide to Writing Risk Management Plans (RMPs)

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

13 Jan 2022 + 3 more dates

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  • Format: Live online, Classroom
  • CPD: 6 hours for your records
  • Certificate of completion

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 intensive one-day course will provide you with an invaluable overview of writing and maintaining RMPs, with practical advice to ensure you achieve regulatory compliance. You will discuss best practice for using the EU templates and risk minimisation tools to enhance the benefit/risk of your product.
The programme has been fully revised to cover the latest updates and new requirements, including amendments made to the previous template.

Benefits of attending:

  • Gain an overview of ICH and EU RMPs – their production and ongoing maintenance
  • Clarify the documentation to be supplied to regulators and the process for RMPs
  • Learn what happened in the EU RMP update and explore the new requirements
  • Discuss the EU templates and their completion – generic and innovator products
  • Understand the relationship between RMPs, post-authorisation safety and efficacy studies, safety reviews and PBRERs
  • Discuss the RMP and risk minimisation follow-up

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, pre-clinical, sales and marketing, legal, commercial and quality.

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The A Practical Guide to Writing Risk Management Plans (RMPs) course will cover:

Introduction, welcome and objectives

An introduction to RMPs

  • Outline and purpose of ICH E2E
  • The implementation of ICH E2E
  • National adoption of ICH E2E
    •  Europe
    • USA
    • Japan
    •  Arab States

Outline of EU RMPs

  • The current EU module V requirements
  • Generic, innovator and advanced therapy products
  • Additional documents to supply to the regulators
  • Safety reporting timelines for RMPs
  • EU RMP update and new requirements

The EU templates and their completion – generic and innovator products

  • The EU generic template – EU requirements (module V)
  • The EU generic RMP versus innovator RMP
  • The EU template for innovator products

Completion of RMPs in other countries

The EU RMP and relationship with other documents

  • The RMP post-authorisation safety and efficacy studies
  • The RMP and PBRERs
  • The RMP and safety reviews

The RMP and Risk Minimisation Follow up

Overview of the sections of the EU RMP template

  • Part I – Product overview
  • Part II – Safety specification modules SI-SVIII
  • Part III – Pharmacovigilance plan including safety studies
  • Part IV – Plans for post-authorisation efficacy studies
  • Part V – Risk minimisation activities including effectiveness measures
  • Part VI – Summary of the risk management plan
  • Part VII – Annexes

Final discussion session

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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.

More details

Book A Practical Guide to Writing Risk Management Plans (RMPs) Live online/Classroom training

13 Jan 2022

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 11549

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 09 Dec

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4 Apr 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11945

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 28 Feb

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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11 Jul 2022

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 11670

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 06 Jun

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3 Oct 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11947

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 29 Aug

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

Reviews of IPI's A Practical Guide to Writing Risk Management Plans (RMPs) training course


Content, presentations and speaker was exceptional.

Jan 28 2021

Anna Shimbulu
Medicines Information and Safety Pharmacist, Therapeutics Information and Pharmacovigilance Centre

Jan 28 2021

It was very informative. The speaker has in depth knowledge of various other country regulations, which helps the trainees to gain more information.

Srinivas Ramesh
National Safety and Regulatory Officer, Fresenius Kabi Ltd & Calea UK Ltd

Jan 28 2021

Really great speaker, I loved his examples and he made the presentation super interesting!

Maja Susa
Safety Specialist III,

Jan 28 2021

Very good. Excellent speaker with vast experience,

Pankaj Gowari
Team Leader - Product Safety and Risk management, apotex research private limited

Jan 27 2020

Graeme was an extremely knowledgeable source who focused on imparting the most important information for us to understand the RMP writing process. I was looking to gain a better understanding of preparing RMPs in accordance with legislation and I believe that Graeme did an excellent job in providing this.

Rex Alexander
Pharmacovigilance Compliance Manager - EUPV, APL Swift Services (Malta) Ltd

Jan 27 2020

Very good course that gave an overall understanding of the RMP and its purpose, presented by a very good communicator with many years of experience.

Tina Maria Greve
Drug Safety Advisor, ALK-Abello A/S

Jan 27 2020

I found the course worthwhile. The presenter was easy to follow and gave practical examples which I found useful.

Laura Maginley
Manager, EU Regulatory Sciences, Biogen

Jan 28 2019

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

Rania Ali
Senior Safety Associate, Amgen

Jan 28 2019

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

Jul 4 2018

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

Harriet Gillespie
Senior Medical Writing Scientist, Janssen-Cilag Limited

Jan 29 2018

I enjoyed Graeme's real-world examples. He addresses people with different knowledge abilities very well.

Alice King
Regulatory Affairs Associate, Creo Pharma Ltd

Jan 29 2018

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

Jul 4 2018

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

Claire McLaughlin
Drug Safety Specialist, Kyowa Kirin International

Jan 29 2018

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

Gabor Varbiro
Medical Adviser, Wockhardt UK Ltd

Jul 4 2016

Fantastic!

Yusouf Bah
Drug Safety and Pharmacovigilance Manager, DBV Technologies

Jul 4 2016

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
Managing Director & EU QPPV, Red Line Pharmacovigilance Ltd

Jul 4 2016

Very useful and engaging.

Lauren Tuitt
ProductLife

Jul 4 2016

Good course, good topic. The speaker is excellent and has great experience.

Jorge Ignacio Gonzalez Borroto
Pharmacovigilance Officer, Grupo Ferrer Internacional SA

UK

  • A Nelson & Co Ltd
  • Accord-UK Ltd
  • Alander Consulting Limited
  • Almac Group Ltd
  • Benchmark Vaccines Limited
  • Biogen
  • consilient health
  • Creo Pharma Ltd
  • DA Consulting Ltd
  • Dermal Laboratories Limited
  • Fresenius Kabi Ltd & Calea UK Ltd
  • Griffiths Medical Writing Ltd
  • Icon Clinical Research (UK) Limited
  • Janssen-Cilag Limited
  • JensonR+ Ltd
  • Kem Pharmaceuticals Limited
  • Kyowa Kirin International
  • Mapi Life Sciences Canada Inc.
  • Mediplex Ltd
  • NDA Regulatory Services
  • Norgine Ltd
  • Panacea Pharma Projects
  • Pharmacovigilance Matters Limited
  • ProductLife
  • PTC Therapeutics
  • Red Line Pharmacovigilance Ltd
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Ltd
  • Veterinary Medicines Directorate
  • Wockhardt UK Ltd

Spain

  • Faes Farma
  • FAES FARMA SA
  • Ferrer Interancional, S.A.
  • Grupo Ferrer Internacional SA
  • Pharma Mar, S.A.
  • PharmaMar

Italy

  • Alfa Wassermann S.p.A.
  • Alfrapharma Srl
  • Chiesi Farmaceutici S.p.a.
  • Recordati
  • ZAMBON SPA

Belgium

  • Colgate-Palmolive R&D
  • Conforma NV
  • Emtex BVBA
  • Janssen Pharmaceutica NV

Denmark

  • ALK-Abello A/S
  • Jacobsen Pharma & MedTech Advice A/S
  • LINK Medical ApS
  • VAN Pharma Consult

France

  • Allergan France S.A.S.
  • BlueReg Pharma Consulting
  • DBV Technologies
  • INNATE PHARMA

Ireland

  • Amryt Pharmaceuticals DAC
  • Aspen Pharma Trading Ltd
  • Real Regulatory Ltd

Germany

  • Medac GmbH
  • MorphoSys AG

Switzerland

  • Idorsia Pharmaceuticals Ltd
  • Swedish Orphan Biovitrum AG

Bulgaria

  • Iggea Ltd

China

  • Roche (China) Holding Ltd

Egypt

  • Amgen

Greece

  • ELPEN PHARMACEUTICAL CO.INC.

India

  • apotex research private limited

Isle of Man

  • Panacea Pharma Projects

Israel

  • Kamada LTD

Korea, Democratic People's Republic Of

  • Archigen Biotech Limited

Malta

  • APL Swift Services (Malta) Ltd

Namibia

  • Therapeutics Information and Pharmacovigilance Centre

Netherlands

  • Sanquin Plasma Products

Poland

  • Covance

Slovak Republic

  • Ewopharma International s.r.o

United States of America

  • Sierra Oncology

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy