Medical Writing Observational Studies EMWA News

Volume 26, Issue 3 - Observational Studies



In this issue, we are bringing to you many updates on different aspects relevant to our medical writing community. Tim Koder from Oxford PharmaGenesis introduces the Open Pharma project, which aims to promote and aid a faster and more transparent publication of medical research. Lillian Sandø, one of the few EMWA members with an ELS suffix, shares her experience with the BELS exam organised for the first time since 1966 in collaboration with the EMWA conference in Birmingham. I personally adhere to her words, and would like to encourage both our editors and writers to take this exam in the future. Also, since our website has been switched to an improved platform, Diarmuid De Faoite tells us all the improvements that this update entails. We urge you to visit the new website if you haven’t done it so far. Finally, Amy Whereat shares the news from the medical writers’ gettogether this summer in Paris.


  1. Duracinsk M, Lalanne C, Rous L, Dara AF, Baudoin L, Pellet C et al. Barriers to publishing in biomedical journals perceived by a sample of French researchers: results of the DIAzePAM study. BMC Med Res Methodol 2017;17:96. DOI: 10.1186/s12874-017-0371-z Available from: http://



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

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