Medical Writing EU Regulations News from the EMA

Volume 29, Issue 3 - EU Regulations

News from the EMA

Abstract

The articles included in this section are a selection from the European Medicines Agency (EMA)’s News and Press Releases archive. More information can be found on the Agency’s website: www.ema.europa.eu.

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Articles

Editorial
President's Message
EMWA News
The In Vitro Diagnosgtics Regulation and the role of medicals writers
Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR
Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers
New documents required by the medical device regulation
Risk management plans in the EU: Managing safety concerns
Scientific advice procedures in the EU – an overview ofthe regulatory background
EU software regulations: The new normal or innovation stagnation?
The new PubMed – underestimated regulatory obstacles
Ethical challenges in acknowledging professional writing support
Publication management software for medical writers
Regulatory Matters
News from the EMA
Medical Devices
Medical Communications and Writing for Patients
Getting Your Foot in the Door
Lingua Franca and Beyond
My First Medical Writing
In the Bookstores
Good Writing Practice

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Editoral Board

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Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: