Medical Writing Observational Studies

Volume 26, Issue 3 - Observational Studies

September 2017

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Editorial

Observations and Observational Studies

Author: Phil Leventhal

President's Message

President's Message

Author: Abe Shevack

EMWA News

EMWA News

Authors: Evguenia Alechine, Tim Koder, Lillian Sandø, Diarmuid De Faoite, Amy Whereat

Feature Articles

RCTs: Can the treatment work? Patient registries: Does the treatment work?

Author: Maria Kołtowska-Häggström

Odd cases and risky cohorts: Measures of risk and association in observational studies

Author: Tom Lang

Guidance for the design and analysis of observational studies: The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative

Authors: Willi Sauerbrei, Gary S. Collins, Marianne Huebner, Stephen D. Walter, Suzanne M. Cadarette, Michal Abrahamowicz

Guidelines for disclosing the results from observational trials

Authors: Andrea Rossi, Carla Benci, Phil Leventhal

Registration and ethics committee approval for observational studies: Current status and way forward

Authors: Namrata Singh, Vasudha

Regulatory submissions of non-interventional post-authorisation safety studies

Author: James M Visanji

Reporting non-interventional post-authorisation safety studies (NI-PASS)

Author: Gregory Morley

Patient-reported outcomes: How useful are they?

Author: Silvia Paz Ruiz

EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans

Authors: Tiziana von Bruchhausen, Sven Schirp

Mentoring tomorrow’s medical writers

Author: Kathryn Lee

ICMJE to mandate data sharing statements

Author: Stephen Gilliver

News from the EMA

News from the EMA

Author: Anuradha Alahari

Regular Sections

Journal Watch

Author: Hervé Maisonneuve

Getting Your Foot in the Door

Authors: Raquel Billiones, Derek K Ho, Laura Rodriguez

In the Bookstores

Author: Nathan D. Susnik

Regulatory Matters

Author: Gregory Morley

Medical Communications

Authors: Lisa Chamberlain James, Rossella Ferrari

The Webscout

Author: Karin Eichele

Teaching Medical Writing

Author: Claire Gudex

Good Writing Practice

Authors: Amy Whereat, Wendy Kingdom

Out On Our Own

Out on Our Own

Authors: Satyendra S. Shenoy, Evguenia Alechine

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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