Medical Writing Risk Management A shot at demystifying the risk management plan for medical writers

Volume 24, Issue 2 - Risk Management

A shot at demystifying the risk management plan for medical writers


A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a step-by-step approach, the medical writer is led through the RMP template with the aim of taming this mystical beast.

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  1. Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 1). EMA/838713/2011 Rev 1. European Medicines Agency [2014 Apr 15; cited 2015 Jan 23]. Available from:
  2. Key C, Mulchrone B, Wai K. The value of reviewing existing EU risk management plans. RAJ Pharma. 2010;79–84.
  3. Guidance on format of the risk-management plan in the European Union. European Medicines Agency [cited 2015 Jan 23]. Available from:
  4. Richardson SJ. Strategic medical writing in the post-authorisation phase. Med Writing. 2014;23(4):267–72.
  5. ICH harmonised tripartite guideline: Pharmacovigilance planning E2E. International Conference on Harmonisation [2004; cited 2015 Feb 1]. Available from:
  6. Chamberlain James L, Creuwels LAJM, Davies M. Risk management plans – new challenges for a new era. Regulatory Rapporteur. 2014;11(6):4–7.
  7. Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 1). EMA/204715/2012 Rev 1. European Medicines Agency [2014 Apr 15; cited 2015 Jan 23]. Available from:
  8. Orleans-Lindsay J. Appendix 5: The new EU risk management plan. In: Pharmacovigilance medical writing: A good practice guide. Chichester, UK: Wiley-Blackwell; 2012, p. 215–25.



Risk Management
President's Message
The changing face of (benefit-)risk management
Pharmacovigilance medical writing: An evolving profession
A shot at demystifying the risk management plan for medical writers
Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?
Special section: Winners of the Geoff Hall Scholarship essay competition
News from the EMA
Profile: An interview with Ingrid Edsman on why attending EMWA conferences is so rewarding!
The Webscout
In the Bookstores
Regulatory Writing: Review process in regulatory writing
Lingua Franca and Beyond
Gained in Translation
Manuscript Writing
English Grammar and Style: Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 3 - Double syntactic unit revision and syntactic position revision
Out On Our Own


The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk