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.
Visit the EMWA website
Search
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
Member Login
Links
Editoral Board
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Waltman
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Alison McIntosh / Stephen Gilliver
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk