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.

1 August 2024
+ 9 October 2024 »
from £549

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

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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

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

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
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

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

1 August 2024

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 13784

GBP 549 649
EUR 789 929
USD 893 1,049

Until 27 Jun

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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for 7 days, no obligation

9 October 2024

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 13923

GBP 549 649
EUR 789 929
USD 893 1,049

Until 04 Sep

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
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; and apply only when booking multiple delegates on the same date.