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

Abstract

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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References

  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: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
  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: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000360.jsp
  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: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf
  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: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162051.pdf
  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.

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Articles

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

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Wendy Kingdom / Amy Whereat

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Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

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Namrata Upadhyay

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Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

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Sam Hamilton

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