Your search for "document review" matched 32 page(s).
Showing results 1 to 10.
Regulatory documents are prepared in a highly collaborative process within tight timelines. The time and the resources required for collecting input, organising document review, and processing the reviewers’ responses often dwarf those invested in…
For science to be understood, assimilated, and further developed, it must be accessible through clear and concise writing. Science is about solving problems that often interlink with each other. To improve the clarity of scientific writing, every…
In medical writing, quality control (QC) means ensuring that a document's content, style, and format are of high quality. This does not just ‘happen’ but is the result of a systemic QC review. These reviews are critical because mistakes can cause…
This article outlines the latest legislation for some of the most common post-authorisation documents (Risk Management Plans, Periodic Safety Update Reports, and Post-authorisation Safety Studies) and explains the role of the strategic medical…
Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…
Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…
In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s…
The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…
Regulatory documents are complex beasts, often requiring input from many different authors. Sometimes, different departments will be responsible for authoring certain sections and the role of the medical writer could perhaps be more accurately…
Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
Medical Writing is listed in the following indexes:
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk