Medical Writing Observational Studies News from the EMA

Volume 26, Issue 3 - Observational Studies

News from the EMA


April, 6, 2017 – Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of its commitment to continuous process improvement. Two new documents aim at improving the safety information and benefit-risk assessment of medicines in the context of the periodic safety update single assessment (PSUSA): Explanatory note to GVP Module VII and Assessors’ questions and answers (Q&A) guidance on PSUR single assessment (PSUSA).



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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