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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.

11 Jul 2022

& 3 Oct 2022

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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.


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 (More...)

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.

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NEW higher discounts for booking multiple places - 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
11 Jul 2022
Live webinar
UK (London)
11 Jul 2022
Live webinar
UK (London)
GBP 599.00
EUR 859.00
USD 970.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
3 Oct 2022
Face-to-face, Rembrandt Hotel London
UK (London)
3 Oct 2022
Rembrandt Hotel London
UK (London)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 29 Aug*
Enrol now
to attend
Rembrandt Hotel London
  • 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

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 6 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Accord-UK Ltd
  • Alfrapharma Srl
  • ALK-Abello A/S
  • Alliance Healthcare
  • Almac Group
  • Biogen
  • Blue Reg Pharma Consult
  • Colgate-Palmolive R&D
  • Conforma NV
  • Consilient Health
  • Creo Pharma Ltd
  • DBV Technologies
  • Diamond PV Services Ltd
  • Ewopharma International s.r.o
  • Faes Farma
  • Fresenius Kabi Ltd & Calea UK Ltd
  • Icon Clinical Research (UK) Limited
  • Jacobsen Pharma & MedTech Advice A/S
  • Janssen Pharmaceutica NV
  • Jenson R+ Ltd
  • JensonR+ Ltd
  • Mediplex Ltd
  • Parexel International
  • Pharma Mar, S.A.
  • PTC Therapeutics
  • Red Line Pharmacovigilance
  • Therapeutics Information and Pharmacovigilance Centre
  • VAN Pharma Consult

The presentation was very clear with lots of examples.

Liji Sasidharan, Senior Manager Benefit-Risk team, Diamond Pharma Services (A Propharma Group Company), Jan 22

The presentation was very clear with lots of examples

Liji Sasidharan, Senior Manager Benefit-Risk team, Diamond Pharma Services (A Propharma Group Company), Jan 22

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

Maja Susa, Safety Specialist III, Jan 21

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 21

Very good. Excellent speaker with vast experience,

Pankaj Gowari, Team Leader - Product Safety and Risk management, apotex research private limited, Jan 21

Content, presentations and speaker was exceptional.

Anna Shimbulu, Medicines Information and Safety Pharmacist, Therapeutics Information and Pharmacovigilance Centre, Jan 21

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 20

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 20

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 20

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, Jan 19

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 19

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

Harriet Gillespie, Senior Medical Writing Scientist, Janssen-Cilag Limited, Jul 18

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

Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International, Jul 18

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, Jan 18

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 18