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 the full article
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
Member Login
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Waltman
Associate Editors
Section Editors
Biotechnology
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Alison McIntosh / Stephen Gilliver
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