Medical Writing Post-Approval Regulatory Writing News from the EMA

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

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk