Medical Writing Statistics Medical Communications

Volume 25, Issue 3 - Statistics

Medical Communications


Anyone working in pharmacovigilance (PV) will already have spent many months working their way through the ever changing updates and reforms to the Risk Management Plan (RMP), and the newly legislated RMP summary. Those not working in PV will probably also have heard all about it (if only through the tortured wails of their PV colleagues!). To everyone’s delight and amazement, we survived the pilot phase; consultation comments have been received and a new and improved version is imminent. We all eagerly await the revision of the RMP summary in particular: will the original concerns be addressed? Will we still be asked to produce a single document that can satisfy both professional healthcare providers and the general public in one fell swoop? Will the RMP summary achieve its aim of increasing transparency for the lay audience?? We will find out in time, I’m sure. But in the meantime, I’m delighted to present to you a really excellent article from Tizianavon Bruchhausen and Stefanie Rechtsteiner. Tiziana and Stefanie chart beautifully the evolution of, and challenges posed, conquered, and still to be undertaken, by the RMP summary guidance. This article really should be called ‘Everything you wanted to know about the RMP summary but were afraid to ask‘ and I will be printing it out and pinning it to my wall!

Download the full article


  1. Transparency. European Medicines Agency [cited 2016 July 04]. Available from:
  2. Von Bruchhausen T and Prechtel K. Pharmacovigilance medical writing: an evolving profession. Medical Writing 2015;24 (2):66-71.
  3. Chamberlain-James L. Risk management plans – New challenges for a new era. Regulatory Rapporteur 2014;11(6):4-7.
  4. Guidance on format of the risk management plan (RMP) in the EU – in integrated format. EMA/PRAC/613102/2015 Rev.2 accompanying GVP Module V Rev.1. European Medicines Agency; 2013 Jul 25 [cited 2016 Jul 04]. Available from:
  5. Guideline on good pharmacovigilance practices (GVP). Module V – Risk management systems (Rev 1). European Medicines Agency and Heads of Medicines Agencies; 2014 Apr 15 [cited 2016 Jul 04]. Available from:
  6. Chamberlain-James L. Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations. Medical Writing 2015;24(4):195-9.
  7. Prechtel K and Rechtsteiner S. Medical writing for two audiences – The RMP public summary. Medical Writing 2015;24(4):200-4.
  8. Juan Garcia Burgos, EMA. Publication of Risk Management Plan (RMP) summaries: Analysis of the experience of the 1-year pilot phase. Lecture presented at PCWP meeting, 2015.
  9. Raynor T. Does transparency in medicines information deliver benefits to patients? Lecture presented at DIA Euromeeting, Hamburg, 2016.
  10. Caroline Voltz-Girolt, EMA. RMP template. 4th stakeholders platform – operation of EU pharmacovigilance legislation; RMP activities update session. Lecture presented at the 4th stakeholders platform, 2015.
  11. Pharmacovigilance Risk Assessment Committee (PRAC). Minutes of the PRAC meeting on 11-14 January 2016. EMA/PRAC/92676/2016 Procedure Management and Committees Support Division [cited 2016 Jul 11] Available from: GB/document_library/Minutes/2016/03/WC500202623.pdf
  12. Guideline on good pharmacovigilance practices (GVP). Module V – Risk management systems (Rev 2) – draft for public consultation. European Medicines Agency and Heads of Medicines Agencies; 2016 Feb 24 [cited 2016 Jul 04]. Available from:
  13. Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format. EMA/PRAC/613102/2015 Rev.2 accompanying GVP Module V Rev.2. European Medicines Agency; 2016 Feb 29 [cited 2016 Jul 04]. Available from:



Statistics for medical writers
President's Message
History of biostatistics
The illusion of certainty and the certainty of illusion
Never P alone: The value of estimates and confidence intervals
A medical writer's guide to meta-analysis
Study design made easy
Statistical analyses and methods in the published literature: The SAMPL guidelines
How to interpret and report the results from multivariable analyses
Biostatistics and medical writing: Synergy in preparing clinical trials documents
Best friends forever: A pattern of collaboration between medical writers and biostatisticians within the Russian CRO
Where have all the UK entry level pharmaceutical regulatory medical writing jobs gone?
News from the EMA
Journal Watch
In the Bookstores
The Webscout
Good Writing Practice
Medical Communications
Getting Your Foot in the Door
Lingua Franca and Beyond
Gained in Translation
Teaching Medical Writing
Profile: An interview with Professor Peter Jüni on methodology and statistics in scientific manuscripts
Out On Our Own


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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