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A Practical Guide to Writing Risk Management Plans (RMPs) In-house Training

This course helps you understand the relationship between RMPs and safety reviews, PBRERs/DSURs, licence submissions (CTD), and their ongoing maintenance.

★★★★★ "Specific, accurate and useful."

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Course overview

In the EU, all companies are required to provide Risk Management Plans (RMPs) for every new product, including both generic medicines and new chemical entities, and to maintain and update these plans throughout the entire lifecycle of a medicine.

This intensive one-day course delivers a clear, practical, and comprehensive overview of how to write, maintain, and update RMPs, equipping you with expert guidance and real-world insights to help you achieve and maintain full regulatory compliance with confidence.

You will gain practical, actionable advice on best practice for using EU templates and risk minimisation tools, enabling you to strengthen benefit–risk profiles and enhance regulatory submissions. Through expert-led discussion, you will build a robust understanding of how to apply regulatory expectations effectively in your daily work.

The course reflects the latest regulatory updates and new requirements, including amendments made to the previous template - ensuring the content is fully current, relevant, and immediately applicable.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Gain a clear overview of ICH and EU RMPs, from production through to ongoing maintenance
Clarify what documentation regulators require and how the RMP process works
Learn what changed in the EU RMP update and understand the new requirements
Discuss EU templates and their completion for both generic and innovator products
Look beyond the EU at other countries requiring RMPs to be implemented
Understand how RMPs connect with post-authorisation studies, safety reviews, and PBRERs
Discuss RMP follow-up and risk minimisation activities

Who should attend

This course is ideal for professionals working in pharmacovigilance who are involved in writing RMPs, including medical directors and QPPVs responsible for approving these plans.

It is also highly relevant for those working closely with pharmacovigilance, including professionals in:

Regulatory affairs
Clinical and pre-clinical
Sales and marketing
Legal
Commercial
Quality Assurance

Popular with...

This course has proven particularly popular among our customers in these roles:

Clinical Drug Safety Officer
EU QPPV
Medical Writer
Pharmacovigilance and Medical Information Officer
Senior Regulatory Manager

This 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

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

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

Overall, very good. Detailed presentations that were easy to follow.

Jul 11 2025

Kristen Mandello United States of America
Associate Director, Zoetis

Nov 5 2024

[Speaker] has a really large and great experience and knowledge on all areas of PV. Overall good.

Dorte Jensen Denmark
QPPV Deputy, 2care4 Generics ApS

Oct 5 2023

Specific, accurate and useful.

Valdas Liukaitis Lithuania
SMCA of Lithuania

Jan 19 2023

Experienced and knowledgeable speaker. Answered all questions and presented in a clear and concise manner.

Sheraz Hussain United Kingdom
Snr PV PM, N/A

Jul 11 2022

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.

Magali Le Goff France
Director Scientific Writing & Regulatory Sciences, BlueReg

Jan 13 2022

The presentation was very clear with lots of examples

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

Jun 28 2021

Content, presentation and speaker - excellent. Very good training.

Dayna Athanasiou United Kingdom
Pharmacovigilance scientist, DA Consulting Ltd

Jan 28 2021

Content, presentations and speaker was exceptional.

Anna Shimbulu Namibia
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 United Kingdom
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 United Kingdom
Safety Specialist III,

Jan 28 2021

Very good. Excellent speaker with vast experience,

Pankaj Gowari India
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 Malta
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 Denmark
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 United Kingdom
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 Egypt
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 United Kingdom
Quality Manager, Benchmark Vaccines Limited

Jul 4 2018

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

Harriet Gillespie United Kingdom
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 United Kingdom
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 United Kingdom
Medical Adviser, Wockhardt UK Ltd

Jul 4 2018

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

Claire McLaughlin United Kingdom
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 United Kingdom
Medical Adviser, Wockhardt UK Ltd

Jul 4 2016

Fantastic!

Yusouf Bah France
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.