Volume 22, Issue 2 - Medical Writing Around the World
Regulatory medical writing in Switzerland
Author: Raquel Billiones
Abstract
Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and cites examples of Swiss-specific regulatory documents.
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References
- Verordnung über klinische Versuche mit Heilmitteln (VKlin) [2001 Oct 17] Available from: http://www.admin.ch/ch/d/sr/812_214_2/index.html
- Swissmedic Information Sheet FAQ [2012 Dec]. Available from: http://www.swissmedic.ch/bewilligungen/00089/00282/index.html
- Bundesgesetz über die Forschung am Menschen (Humanforschungsgesetz, HFG) [30 Sept 2011]. Available from: http://www.admin.ch/ch/d/ff/2011/7415.pdf
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Articles
Medical writing around the world
Message from the President
The yin and yang of medical writing in China
The changing face of medical writing in India
Medical writing in India at a crossroads
Medical writing in the Middle East
Medical writing in Finland
On the western edge of Europe – medical writing in Portugal
Announcing AERTeM, the Spanish Association of Medical Writers
From editors abroad into businesswomen back in Brazil
Science writing workshops for AIDS vaccine researchers in Africa
Medical postcard from Australia, the world's largest island
Teaching English for Medical Academic Purposes at the Faculty of Medicine in Belgrade, Serbia
Regulatory medical writing in Switzerland
Medical writing in the Russian Federation: Promises and pitfalls
Report on the EMA Workshop on clinical trial data and transparency
Potential implications of wider data transparency in medical communications
The need for registration of preclinical studies
Mentorship in EMWA: A perspective
In the Bookstores
The Webscout
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English Grammar and Style
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Editoral Board
Editor-in-Chief:
- Phillip Leventhal (4Clinics, Lyon, France)
Co-Editor:
- Stephen Gilliver (TFS Trial Form Support, Lund, Sweden)
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Katharine Webb (INC Research, in Munich, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
Section Editors:
- Alison McIntosh (ICON Clinical Research, Hampshire, UK)
- Karin Eichele (Novartis Pharma, Nürnberg, Germany)
- Greg Morley (Freelance, Madrid, Spain)
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting, Norfolk, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Simon Page (Cambridge Medical Communication Ltd, Cambridge, UK)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Satyen Shenoy (Describe Scientific Writing & Communications, Cologne, Germany)
- Claire Gudex (Klinisk Institut, Odense, Denmark)
- Evguenia Alechine (Epsilon Scientific Communication, Buenos Aires, Argentina)
- Beatrix Doerr
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)