Medical Writing Generics and biosimilars

Volume 28, Issue 2 - Generics and biosimilars

June 2019

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Introduction

Introduction
Author: Diana Radovan

President's Message

President’s Message
Authors: Barbara Grossman, Tiziana von Bruchhausen

EMWA News

EMWA News
Author:

Feature Articles

Regulatory pathways for development and submission activities
Author: Yousuf Mohiuddin Mohammed

Biosimilar development – an overview
Author: Diana Radovan

Statistical principles in biosimilar development
Authors: Alison Balfour, Susanne Schmitt

Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Authors: Dr Katharina Brauburger, Sabrina Heisel-Stoehr

Medical writing for generics throughout the life cycle
Author: Sandra Götsch -Schmidt

Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Authors: Tiziana von Bruchhausen, Kerstin Prechtel, Stefanie Rechtsteiner

Layperson materials in the sphere of biosimilars and generic medicines
Authors: David McMinn, Craig Scott, Baxter Jeffs

Insulin biosimilars
Author: Krithika Muthukumaran

Biosimilars: Change, challenge, and accomplishments
Author: Martin Mewies

ICMJE requirements for sharing individual participant data from interventional clinical trials
Authors: Kathy B. Thomas, Robert A. Paarlberg

Medicinal products and medical devices in clinical trials conduct and disclosure
Authors: Raquel Billiones, Kathy B. Thomas

Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Author: Dr Sybille M. Eibert

Collecting metrics in medical writing – the benefits to you and your business
Authors: Nicola Haycock, Keith Dawes

Document management systems for medical writing
Author: Brendan Thorne

Special Section

James Visanji Tribute
Author:

Winner of the Geoff Hall Scholarship Essay Competition
Authors: Lisa Chamberlain James, Abbie Fearon

Regular Sections

Regulatory Matters
Author: Jennifer Morris

News from the EMA
Authors: Anuradha Alahari, Monika Benstetter

Getting Your Foot in the Door
Author: Raquel Billiones

Veterinary Medical Writing
Author: Karim Montasser

Teaching Medical Writing
Author: Claire Gudex

Medical Devices
Author: Beatrix Döerr

My First Medical Writing
Author: Evguenia Alechine

Journal Watch
Author: Hervé Maisonneuve

Good Writing Practice
Authors: Wendy Kingdom, Amy Whereat

Regulatory Public Disclosure
Author: Sam Hamilton

Out on Our Own
Author:

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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

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Freelancing

Tiziana von Bruchhausen

Pharmacovigilance

Clare Chang / Zuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk