Medical Writing Observational Studies Observations and Observational Studies

Volume 26, Issue 3 - Observational Studies

Observations and Observational Studies


Our publication, Medical Writing, has always been a work in progress, continually evolving to meet our members’ needs and desires. Originally a four-page newsletter called the EMWA Newsletter, it was renamed The Write Stuff in 1998 and, under the guidance of Elise Langdon-Neuner, grew to a larger publication renamed Medical Writing in 2011. Since taking over as Editor in 2012, I have focused on shifting Medical Writing to an in-house publication and to a more dynamic format.
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Observations and Observational Studies
President's Message
RCTs: Can the treatment work? Patient registries: Does the treatment work?
Odd cases and risky cohorts: Measures of risk and association in observational studies
Guidance for the design and analysis of observational studies: The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative
Guidelines for disclosing the results from observational trials
Registration and ethics committee approval for observational studies: Current status and way forward
Regulatory submissions of non-interventional post-authorisation safety studies
Reporting non-interventional post-authorisation safety studies (NI-PASS)
Patient-reported outcomes: How useful are they?
EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans
Mentoring tomorrow’s medical writers
ICMJE to mandate data sharing statements
News from the EMA
Journal Watch
Getting Your Foot in the Door
In the Bookstores
Regulatory Matters
Medical Communications
The Webscout
Teaching Medical Writing
Good Writing Practice
Out on Our Own

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Editoral Board



Managing Editor

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Associate Editors:

Section Editors:

Ad-hoc Editors:

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

Editor Emeritus: