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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.

13 Jan 2022

& 4 Apr 2022 , 11 Jul 2022 , 3 Oct 2022

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Details

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.

Programme

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

Presenter

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.

Book now

Book now

13 Jan 2022
Live webinar
13 Jan 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 9 Dec*
Enrol now
to attend
Live webinar
4 Apr 2022
Face-to-face, (venue not yet confirmed)
4 Apr 2022
Face-to-face
(venue not yet confirmed)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 28 Feb 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
11 Jul 2022
Live webinar
11 Jul 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 6 Jun 22*
Enrol now
to attend
Live webinar
3 Oct 2022
Face-to-face, (venue not yet confirmed)
3 Oct 2022
Face-to-face
(venue not yet confirmed)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 29 Aug 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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

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...

  • Alfa Wassermann S.p.A.
  • Alfrapharma Srl
  • ALK-Abello A/S
  • Almac Group
  • apotex research private limited
  • Biogen
  • DBV Technologies
  • Dermal Laboratories Ltd
  • Emtex BVBA
  • Ewopharma International s.r.o
  • Faes Farma
  • FAES FARMA SA
  • Ferrer Internacional, S.A.
  • Fresenius Kabi Ltd & Calea UK Ltd
  • Idorsia Pharmaceuticals Ltd
  • Jacobsen Pharma & MedTech Advice A/S
  • Janssen-Cilag Limited
  • Kem Pharmaceuticals Limited
  • Medac GmbH
  • NDA Regulatory Science Ltd
  • Pharmacovigilance Matters Limited
  • ProductLife
  • Recordati
  • Red Line Pharmacovigilance
  • Roche Products Ltd
  • Rosemont Pharmaceuticals Ltd
  • Sierra Oncology
  • Swedish Orphan Biovitrum AG
  • Wockhardt UK Ltd
  • ZAMBON SPA

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

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

Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd, Jan 18

Very useful and engaging.

Lauren Tuitt, ProductLife, Jul 16