Your search for "pharmacovigilance" matched 41 page(s).
Showing results 11 to 20.
Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…
The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the marketing authorisation holder for their authorised medicinal products. The PSMF is intended to be a live, custom-made document…
A useful reference for writing pharmacovigilance documents Like other areas of medical writing, pharmacovigilance (PV) medical writing has many detailed regulations, guidance documents, and templates associated with it. As such, there is a…
Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…
The global population is ageing, but inequalities remain in older people's access to treatment, especially people 75 years of age and older. These people receive less frequent interventions and lower quality medical treatment than their younger…
The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…
One of the benefits of being an EMWA member is having access to the webinar programme. In 2018, we are providing a new webinar almost every month of the year either in live or recordedformats. Thanks to our wonderful speakers, this year we’ve had…
October 5, 2018 and November 16, 2018 – Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Grampositive classes. EMA’s Pharmacovigilance Risk Assessment Committee…
How does a team of medical writers working in different countries navigate different time zones and cultures to get their work done remotely? In this interview, a team of six medical writers and one editor working at P95, a private research…
From scurvy to Covid-19: The role of clinical trials, and medical writing’s crucial role in the process The medical writing community is intrinsically involved in regulatory documentation that spans the entire timeline of clinical research – from…
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
AI/Automation
Biotechnology
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Publications
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Freelancing
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Layout Designer
Chris Monk