Volume 25, Issue 3 - Statistics
Medical Communications
Authors: Lisa Chamberlain James, Tiziana von Bruchhausen, Stefanie Rechtsteiner
Abstract
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!
Enjoy.
Bestest.
Download the full article
References
- Transparency. European Medicines Agency [cited 2016 July 04]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000526.jsp&mid=WC0b01ac0580789730
- Von Bruchhausen T and Prechtel K. Pharmacovigilance medical writing: an evolving profession. Medical Writing 2015;24 (2):66-71.
- Chamberlain-James L. Risk management plans – New challenges for a new era. Regulatory Rapporteur 2014;11(6):4-7.
- 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: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/11/WC500134650.pdf
- 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: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
- 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.
- Prechtel K and Rechtsteiner S. Medical writing for two audiences – The RMP public summary. Medical Writing 2015;24(4):200-4.
- 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.
- Raynor T. Does transparency in medicines information deliver benefits to patients? Lecture presented at DIA Euromeeting, Hamburg, 2016.
- 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.
- 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: http://www.ema.europa.eu/docs/en_ GB/document_library/Minutes/2016/03/WC500202623.pdf
- 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: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/02/WC500202424.pdf
- 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: www.ema.europa.eu/.../en_GB/document_library/Regulatory_and_procedural_guideline/2016/02/WC500202373.doc
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