Your search for "regulation" matched 208 page(s).
Showing results 61 to 70.
In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…
An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…
Section Editors: Clare Chang, Zuo Yen Lee Navigating the regulatory landscape of gene therapy Medical Writing. 2024;33(4):89–93. https://doi.org/10.56012/wjxo2860
Two years into the pandemic outbreak, our lives have changed one way or another. The pandemic not only has impacted our lifestyle, it might also have impacted our career at some level. We might find ourselves needing to venture out onto new paths,…
Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the…
Section Editors: Clare Chang, Zuo Yen Lee In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang Authors: Yoko Komatsuzaki, Julia Forjanic Klapproth Authoring and reviewing complex, parallel regulatory…
Contributors: Ri Xu (author) Zuo Yen Lee (section editor), Clare Chang (section editor) Hand and back muscle pain and how to avoid them: A regulatory writer's story Ri Xu Medical Writing. 2022;31(3)68-71. https://doi.org/10.56012/thzz1704
Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…
In this information-packed edition of Regulatory Public Discussion, Sam Hamilton provides detailed comparisons of regulatory templates and updates on processes for the Clinical Trials Information System. Contributor: Sam Hamilton (author and…
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 Brooks Waltman
Associate Editors
Section Editors
AI/Automation
Biotechnology
Digital Communication
EMWA News
Freelancing
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Pablo Izquierdo / Alison McIntosh
In the Bookstores
Publications
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Layout Designer
Chris Monk