Searche

Your search for "data access" matched 56 page(s).

Showing results 11 to 20.

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

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…

Thriving in the data economy as data-fluent PhD graduates - Volume 29, Issue

We are living in an era of data deluge. With the amount of data generated increasing rapidly, organisations are in high need of individuals who are skilled at managing, analysing, and interpreting data. Data literacy is deemed as a crucial…

Defining the quality of data within rare disease registries: A systematic review - Volume 34, Issue

Rare diseases have a low prevalence within society, resulting in limited awareness and challenges with data availability for research. While rare disease registries offer valuable data, ensuring quality of the data is essential. This review explores…

The value of registry data in the clinical evaluation of medical devices - Volume 29, Issue

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…

Real-world data and evidence: A European regulatory perspective - Volume 34, Issue

The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from…

Embracing the potential of real-world data: An industry perspective - Volume 34, Issue

Randomised controlled trials are the gold standard for evaluating the efficacy of medical interventions, offering robust evidence through controlled designs that minimise bias. However, their generalisability to diverse patient populations is typical…

Real-world evidence and real-world data in contemporary healthcare: A critical overview - Volume 34, Issue

Science for all: Is it all about the publication of data, or beyond? - Volume 31, Issue

This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…

Partnering with patient associations: Engaging medical writers to support health literacy for patients - Volume 29, Issue

As patients are increasingly involved in healthcare decisions, there is a growing need for them to have access to appropriate health information. Medical writers, being a link between medical research and published data, are well placed to make…

Visit the EMWA website

Search

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Scope

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: