Abstract
Back in 2016, the Out on Our Own editors reached out to groups in European countries who had established informal medical writers’ gatherings. It was great to see that groups had appeared in Germany, France, the UK, and the Netherlands. Here, I asked the Berlin group and the Netherlands group to give us a recap on their gatherings.
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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
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Regulatory Public Disclosure
Out on Our Own
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Editor-in-Chief:
- Phillip Leventhal (Evidera, Lyon, France)
Co-Editor:
Managing Editor
- Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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Associate Editors:
- Anuradha Alahari (PAREXEL International, Paris, France)
- Raquel Billiones (Clinipace, Zurich, Switzerland)
- Barbara Grossman (Hawkeye Medical Limited, Berkshire, UK)
- Joselita T Salita (Freelance, Bremen, Germany)
- Nathan Susnik (Hanover Medical School, Hanover, Germany)
- Clare (Chi-Chih) Chang
- Jonathan Pitt
Section Editors:
- Alison McIntosh
- Wendy Kingdom (Wendy Kingdom Ltd., Dulverton, UK)
- Lisa Chamberlain-James (Trilogy Writing and Consulting Ltd., Cambridge, UK)
- Maria Koltowska-Haggstrom (Proper Medical Writing Warsaw, Poland)
- Laura Collada Ali (Teksema, Cogne, Italy)
- Hervé Maisonneuve (Freelance, Lyon, France)
- Claire Gudex (University of Southern Denmark, Odense, Denmark)
- Sam Hamilton (Newcastle Upon Tyne, UK)
- Anu Alahari
- Evguenia Alechine
- Kelly Goodwin Burri (Stryker GmbH, Selzach, Switzerland)
- Stephen Gilliver
- Amy Whereat
- Jennifer Clemens
- Karim Montasser
- Somsuvro Basu
Ad-hoc Editors:
- Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)
Editor Emeritus:
- Elise Langdon-Neuner (Medical University of Vienna, Austria)