Medical Writing Generics and biosimilars Journal Watch

Volume 28, Issue 2 - Generics and biosimilars

Journal Watch

Abstract

Journal Watch is based on the French language blog, Rédaction Médicale et Scientifique, by Hervé Maisonneuve, available at www.redactionmedicale.fr.

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References

  1. Freeling B, Doubleday ZA, Connell SD. How can we boost the impact of publications? Try better writing. PNAS. 2019;116(2):341 43.
  2. Amrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature. 2019;567:305 7.
  3. Ioannidis JPA. The importance of predefined rules and prespecified statistical analyses: Do not abandon significance. JAMA Published online April 4, 2019. doi:10.1001/jama.2019.4582
  4. Broderick NA, Casadevall A. Gender inequalities among authors who contributed equally. eLife 2019;8:e36399.
  5. Fox CW, Paine CET. Gender differences in peer review outcomes and manuscript impact at six journals of ecology and evolution. Ecol Evol. 2019;00:1–21.
  6. Wickman C, Fitzgerald E. Writing and science: An editorial perspective. Written Communication. 2019, Vol. 36(1) 3–8.

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Articles

Introduction
James Visanji Tribute
President’s Message
EMWA News
Regulatory pathways for development and submission activities
Biosimilar development – an overview
Statistical principles in biosimilar development
Writing biosimilar clinical study reports and submission documents – what to expect and what to consider
Medical writing for generics throughout the life cycle
Same but different: Basic tools for biosimilar and generic pharmacovigilance writing
Layperson materials in the sphere of biosimilars and generic medicines
Insulin biosimilars
Biosimilars: Change, challenge, and accomplishments
ICMJE requirements for sharing individual participant data from interventional clinical trials
Medicinal products and medical devices in clinical trials conduct and disclosure
Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov
Collecting metrics in medical writing – the benefits to you and your business
Document management systems for medical writing
Winner of the Geoff Hall Scholarship Essay Competition
Regulatory Matters
News from the EMA
Getting Your Foot in the Door
Veterinary Medical Writing
Teaching Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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

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 ChangZuo 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