Volume 24, Issue 4 - Writing for Lay Audiences
Medical writing for two audiences – The RMP public summary
Authors: Kerstin Prechtel, Stefanie Rechtsteiner
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.
Download the full article
References
- 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
- Von Bruchhausen T, Prechtel K. Pharmacovigilance medical writing: An evolving profession. Med Writing. 2015;24(2):66–71.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Visit the EMWA website
Search
Articles
Member Login
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Associate Editors
Section Editors
Biotechnology
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk