Abstract
November 15, 2016 — The EMA, in cooperation with the European Commission and the Member States of the EU, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline was open for public consultation until 28 February 2017.
Download Full Article
You must be a member of EMWA in order to download the full article.
EMWA members please log in to download the full article.
If you would like to become a member of EMWA, please join here.
References
- Sergio Bonini, and Guido Rasi. First-in-Human Clinical Trials – What We Can Learn from Tragic Failures, N Engl J Med 2016; 375:1788-1789.
Visit the EMWA website
Search
Articles
Writing Better
President’s Message
EMWA News
Advancing the Medical Writing profession: The Joint Position Statement on the Role of Professional Medical Writers
AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers
EMWA’s Special Interest Groups (SIGs)
Finding the action in your writing: Avoiding nominalisation
Removing the dead wood
Writing economically in medicine and science: Tips for tackling wordiness
How to shorten a text by up to 30% and improve clarity without losing information
Troublesome words
Can you recognise the four main ways that English sentences can be structured?
Three strategies to help you write clearly for a lay audience
Structuring paragraphs
A checklist to improve your writing
Results of the 2016 EMWA member survey
News from the EMA
Getting Your Foot in the Door
Teaching Medical Writing
In the Bookstores
Lingua Franca and Beyond
The Webscout
Good Writing Practice
Medical Communications
Profile: An Interview with Michael Markie - an open science and open data advocate
Out on Our Own
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
show all +
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 (ICON Clinical Research, Hampshire, UK)
- 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
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)