Medical Writing Observational Studies Regulatory Matters
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Volume 26, Issue 3 - Observational Studies

Regulatory Matters

Abstract

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important company milestone, but there is still plenty of work to do. After validation of the submission, the agency reviews the documentation, and a process of back-and-forth begins in which positions are negotiated and concessions may be made.

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Articles

Observations and Observational Studies
President's Message
EMWA News
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

Editor-in-Chief:

Co-Editor:

Managing Editor

  • Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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Associate Editors:

Section Editors:

Ad-hoc Editors:

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

Editor Emeritus: