Volume 23, Issue 4 - Post-Approval Regulatory Writing
News from the EMA
Abstract
The articles included in this section are a selection from the EMA's news and press release archive for March–June 2014. More information on the work of the EMA can be found on its website: http://www.ema.europa.eu.
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Articles
Post-approval regulatory writing
President's Message
Responding to concerns over the PSMF: Inspectors offer key insights
Post-approval regulatory writing – How different is it from writing pre-approval documents?
Strategic medical writing in the post-authorisation phase
Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report
Writing publications for advisory boards
The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance
Profile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting
English Grammar and Style
News from the EMA
The Webscout
In the Bookstores
Out On Our Own
The Light Stuff
Member Login
Links
Editoral Board
Editor-in-Chief:
- Phillip Leventhal (Evidera, Lyon, France)
Co-Editor:
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)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
- Clare (Chi-Chih) Chang
- Jonathan Pitt
Section Editors:
- Alison McIntosh
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting Ltd., Cambridge, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Claire Gudex (University of Southern Denmark, Odense, Denmark)
- Sam Hamilton (Newcastle Upon Tyne, UK)
- Anu Alahari
- Evguenia Alechine
- Kelly Goodwin Burri (Stryker GmbH, Selzach, Switzerland)
- Stephen Gilliver
- Amy Whereat
- Jennifer Clemens
- Karim Montasser
- Somsuvro Basu
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)