Medical Writing Generics and biosimilars
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Volume 28, Issue 2 - Generics and biosimilars

June 2019

Introduction

Introduction

President's Message

President’s Message

EMWA News

EMWA News

Feature Articles

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

Special Section

James Visanji Tribute

Winner of the Geoff Hall Scholarship Essay Competition

Regular Sections

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

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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.

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Ad-hoc Editors:

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

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