Medical Writing Writing for Lay Audiences Medical writing for two audiences – The RMP public summary

Volume 24, Issue 4 - Writing for Lay Audiences

Medical writing for two audiences – The RMP public summary

Abstract

With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The most important information is outlined in Part VI of the RMP, which forms the basis for the summary that is subsequently published on the EMA website. For medical writers the task of writing for expert and lay audiences at the same time poses new challenges.

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References

  1. Good pharmacovigilance practices. European Medicines Agency [cited 2015 July 13]. Available from: http://www.ema.europa.eu<http//www.ema.europa.eu/%3E/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp
  2. Von Bruchhausen T, Prechtel K. Pharmacovigilance medical writing: An evolving profession. Med Writing. 2015;24(2):66–71.
  3. 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 2015 July 13]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
  4. Risk-management plans. European Medicines Agency [cited 2015 August 18]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000360.jsp&mid=WC0b01ac058067a113
  5. Guidance on format of the risk management plan (RMP) in the EU – in integrated format. European Medicines Agency [cited 2015 August 20]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/11/WC500134650.pdf
  6. European public assessment reports. European Medicines Agency [cited 2015 July 13]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124
  7. Pharmacovigilance Risk Assessment Committee (PRAC). European Medicines Agency [cited 2015 July 13]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp&mid=WC0b01ac058058cb18
  8. Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency [cited 2015 July 13]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79
  9. Questions and answers on the risk management plan (RMP) summary. European Medicines Agency; 2014 May 05 [cited 2015 July 13]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/05/WC500166101.pdf

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Articles

Writing for lay audiences
President's Message
Writing for lay audiences: A challenge for scientists
Patient education accessibility
Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations
Medical writing for two audiences – The RMP public summary
Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance
Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?
What do writers need to know about user testing?
Medical journalism: Another way to write about science
Elements of storytelling in medical journalism
A stroll through the medical blogosphere
Writing narrative style literature reviews
News from the EMA
Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations
The Webscout
In the Bookstores
Regulatory Writing
Lingua Franca and Beyond
Gained in Translation
English Grammar and Style
Out On Our Own

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Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

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Victoria White

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Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

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AI/Automation

Jennifer Bell

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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

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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

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

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

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