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A Practical Guide to Writing Risk Management Plans (RMPs) Training Course

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

★★★★★ "Excellent speaker who managed to keep the listener's attention through a complex document and proces... more"

19 Jan 2023
+ 3 more dates

Need help?  Enrol or reserve

  • 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

Enrol or reserve

Graeme Ladds
PharSafer Associates Ltd

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

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

19 Jan 2023

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 12531

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 15 Dec

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Not ready to book yet?

for 7 days, no obligation

20-21 Apr 2023

Live online

13:05-16:30 UK (London) (UTC+01)
14:05-17:30 Paris (UTC+02)
08:05-11:30 New York (UTC-04)
Course code 12488

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 16 Mar

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Not ready to book yet?

for 7 days, no obligation

24 Jul 2023

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 12265

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 19 Jun

View basket 

 
Not ready to book yet?

for 7 days, no obligation

2 Oct 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12349

  • GBP 649 749
  • EUR 939 1,079
  • USD 1,053 1,209

Until 28 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 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

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


Excellent speaker who managed to keep the listener's attention through a complex document and process. Very useful slides that I will consult when requested assistance with RMP from clients. I particularly enjoyed the explanation of US vs Japan vs EU expectations in terms of safety.

Jul 11 2022

Magali Le Goff
Director Scientific Writing & Regulatory Sciences, BlueReg

Jan 13 2022

The presentation was very clear with lots of examples

Liji Sasidharan
Senior Manager Benefit-Risk team, Diamond Pharma Services (A Propharma Group Company)

Jan 13 2022

The presentation was very clear with lots of examples.

Liji Sasidharan
Senior Manager Benefit-Risk team, Diamond Pharma Services (A Propharma Group Company)

Jan 28 2021

Content, presentations and speaker was exceptional.

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

United Kingdom

  • A Nelson & Co Ltd
  • Accord-UK Ltd
  • Alander Consulting Limited
  • Alliance Healthcare
  • Almac Group Ltd
  • Benchmark Vaccines Limited
  • Biogen
  • consilient health
  • Creo Pharma Ltd
  • DA Consulting Ltd
  • Dermal Laboratories Limited
  • Diamond Pharma Services
  • Diamond Pharma Services (A Propharma Group Company)
  • 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
  • Norgine Ltd
  • Panacea Pharma Projects
  • Pharmacosmos UK
  • Pharmacovigilance Matters Limited
  • ProductLife
  • PTC Therapeutics
  • Red Line Pharmacovigilance Ltd
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Ltd
  • The Boots Company PLC
  • Veterinary Medicines Directorate
  • Wockhardt UK Ltd

Spain

  • Chemo Research S.L.
  • Eignapharma
  • 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
  • recordati spa
  • ZAMBON SPA

France

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

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

India

  • apotex research private limited
  • Parexel
  • Parexel International

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.

Isle of Man

  • Panacea Pharma Projects

Israel

  • Kamada LTD

Korea, Democratic People's Republic Of

  • Archigen Biotech Limited

Lithuania

  • State Medicines Control Agency of Lithuania

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

Enrol or reserve

Run A Practical Guide to Writing Risk Management Plans (RMPs) Live online/Classroom for your team

1 day

Typical duration

Pricing from:

  • GBP 450
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy