Medical Writing Risk Management A shot at demystifying the risk management plan for medical writers
mew-150pxjpg

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.

Download the full article

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.

Search

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

Member Login

Links

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

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: