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A Practical Guide to Writing Risk Management Plans (RMPs)

Management Forum
Course summary
1 day
599 - 699 GBP excl. VAT
English
Professional Training
Next available date: 28/01/2021 - Online courses
Course Dates
Online courses
599 GBP
28/01/2021

Online courses
599 GBP
28/06/2021

London
699 GBP
04/02/2021

London
699 GBP
30/06/2021

A Practical Guide to Writing Risk Management Plans (RMPs)

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

Please note that we are also running:

Book together and save

This meeting runs back-to-back with Producing and Maintaining the Pharmacovigilance System Master File (PSMF). Save an additional £100/€140 if you book both together.

To find out more please call customer services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

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

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

Provider: Management Forum

Management Forum

Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors

Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...


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Contact information for Management Forum

Management Forum

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GU21 5JL Woking

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www.management-forum.co.uk


Reviews by course attendees

Average rating 4.2

Based on 4 reviews

Rania
(4)
Overall, I'm satisfied with the course and i think the sequence of the course topics was very logical and organised although it was condensed.
Jennifer
(4)
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
Claire
(4)
Very knowledgeable. Very well presented and in-depth description presented on each section.