A Practical Guide to Writing Risk Management Plans (RMPs)

Understand RMPs relationship to safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance

27 Jan 2020

& 29 Jun 2020

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 20 Dec

Book now

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 include the latest updates.

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
  • 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, 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

Outline of EU RMPs

  • EU module V requirements
  • Generic, innovator and advanced therapy products
  • Additional documents to supply to the regulators
  • Safety reporting timelines for RMPs

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

Overview of the sections of the EU RMP template (continued)

  • 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

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

27 Jan 2020
27 Jan 2020 Cavendish Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 20 Dec*
Enrol now
29 Jun 2020
29 Jun 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Alander Consulting Limited
  • Alfrapharma Srl
  • ALLERGAN FRANCE S.A.S.
  • Archigen Biotech Limited
  • Benchmark Vaccines Limited
  • Chiesi Farmaceutici S.p.a.
  • Colgate-Palmolive R&D
  • Creo Pharma Ltd
  • DBV Technologies
  • ELPEN Pharmaceutical Co Inc
  • Ewopharma International s.r.o
  • Icon Clinical Research (UK) Limited
  • Iggea Ltd
  • Jacobsen Pharma & MedTech Advice A/S
  • Janssen Pharmaceutica NV
  • Jenson R+ Ltd
  • JensonR+ Ltd
  • Kyowa Kirin Services Ltd
  • LINK Medical ApS
  • Mapi Life Sciences Canada Inc.
  • Medac GmbH
  • Norgine Ltd.
  • PTC Therapeutics
  • Real Regulatory Ltd
  • Recordati
  • Red Line Pharmacovigilance
  • Sanquin Plasma Products
  • VAN Pharma Consult
  • Wockhardt UK Ltd
  • ZAMBON SPA

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

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.

Rania Ali, Senior Safety Associate, Amgen

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

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

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

Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International

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

Gabor Varbiro, Medical Adviser, Wockhardt UK Ltd

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

I enjoyed Graemes real world examples. He addresses people with different knowledge abilities very well

Alice King, Regulatory Affairs Associate, Creo Pharma Ltd

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

Shirley-Ann Van Der Spuy, EU QPPV, Redline Pharmacovigilance Ltd

Fantastic

Yusouf Bah, Drug Safety and Pharmacovigilance Manager, DBV Technologies

Good course, good topic. Practical details offered, experiences. The speaker is excellent with the topic and has great experience.

Jorge Ignacio Gonzalez Borroto, Pharmacovigilance Officer, Grupo Ferrer Internacional SA

Very useful and engaging

Lauren Tuitt, ProductLife