Your search for "regulatory requirements" matched 73 page(s).
Showing results 21 to 30.
Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…
Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
The Physicians Payment Sunshine Act – casting a shadow over clinical research? In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess…
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…
Canadian and European regulators finalised guidelines that allow for sharing of clinical trial data. To maintain the utility of clinical information, risk-based anonymisation techniques are recommended. It behoves applicants to ensure organisational…
With the emergence of biosimilars, the development process for these drugs is a topic of increasing interest to medical writers. Even though information and educational documents on the concept of biosimilarity areincreasingly publicly available, it…
Medical writing for in vitro diagnostics differs from writing for pharmaceutical products in several ways. The shorter development time and lifecycle of diagnostic assays, different regulatory requirements and approval times, and upcoming changes…
With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…
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