Medical Writing EU Regulations

Volume 29, Issue 3 - EU Regulations

September 2020

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Editorial

Editorial

Author: Ana Madani

President's Message

President's Message

Author: Beatrix Döerr

EMWA News

EMWA News

Author: Somsuvro Basu

Feature Articles

The In Vitro Diagnosgtics Regulation and the role of medicals writers

Authors: Gauri Jawdekar-Abraham, Raquel Billiones

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR

Author: Raquel Billiones

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers

Authors: Shalini Dwivedi, Raina Agarwal, Bhavna Nanda, Prashanth Devappa, Sonali Parmar, Vidhi Vashisht

New documents required by the medical device regulation

Authors: Payal Bhatia, Laura C. Collada Ali, Kelly Goodwin Burri, Gillian Pritchard, Namrata Singh, Namrata Upadhyay

Risk management plans in the EU: Managing safety concerns

Authors: Tiziana von Bruchhausen, Sven Schirp

Scientific advice procedures in the EU – an overview ofthe regulatory background

Authors: Daniela Kenzelmann Broz, Gabriele Galliverti, Anja Bührer

EU software regulations: The new normal or innovation stagnation?

Author: James W. Monroe

The new PubMed – underestimated regulatory obstacles

Authors: Micha Feld, Katharina Neuhäuser, Raquel Marcos Esteban, Florian Tolkmitt, Thomas Brzoska

Ethical challenges in acknowledging professional writing support

Authors: Blair R. Hesp, Marissa Scandlyn

Publication management software for medical writers

Author: Jackie Raskind

Regular Sections

Regulatory Matters

Authors: Jennifer Morris, Eric Rotman

News from the EMA

Author: Anuradha Alahari

Medical Devices

Authors: Kelly Goodwin Burri, Cherry Malonzo Marty, Kerstin Römermann, Wiebke Theilmann

Medical Communications and Writing for Patients

Authors: Lisa Chamberlain James, Joana Fernandes

Getting Your Foot in the Door

Authors: Raquel Billiones, Priyanka Dutta, Michelle Guillemard, Diana Ribeiro

Lingua Franca and Beyond

Authors: Maria Kołtowska-Häggström, Carolyn Brimley Norris

My First Medical Writing

Authors: Evguenia Alechine, Shirene Melissa Singh

In the Bookstores

Authors: Alison McIntosh, Stephen Gilliver

Good Writing Practice

Authors: Wendy Kingdom, Amy Whereat, Michael Lewis Schneir

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Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

Medical Writing is listed in the following indexes:

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Nicole Bezuidenhout

Barbara Grossman

Sampoorna Rappaz

Section Editors

AI/Automation

Biotechnology

Nicole Bezuidenhout

Digital Communication

EMWA News

Freelancing

Ana Sofia Correia

Gained in Translation

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Pablo Izquierdo / Alison McIntosh

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Tiziana von Bruchhausen

Pharmacovigilance

Clare Chang / Zuo Yen Lee

Regulatory Matters

Regulatory Public Disclosure

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Jeff Blair / Luiza Ventura

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Layout Designer

Chris Monk