Your search for "european medicines agency" matched 34 page(s).
Showing results 1 to 10.
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
Access to patient data gathered in clinical trials is a highly controversial and complex issue that needs to balance three aspects: the public right to transparency regarding data used to approve new medicines, protection of the data privacy rights…
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…
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…
A risk management plan (RMP) is a complex regulatory document which is now required in the European Union as part of a medicine's approval process. This article offers practical guidance for medical writers who are interested in writing an RMP. In a…
Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…
Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…
Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…
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
Deputy Managing Editor
Alicia Waltman
Associate Editors
Section Editors
Biotechnology
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
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk