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The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

From the Editor - Volume 32, Issue

The D’s of robotics: Are we ready to delegate? When Shiri Diskin and Daniela Kamir suggested in 2021 to have a Medical Writing issue on automation in medical writing, little did I imagine how imperative this topic would be in 2023. I sincerely…

Artificial Intelligence and Machine Learning - Volume 32, Issue

Guest Editors Daniela Kamir and Shiri Diskin provide an introduction to this issue, whose theme Artificial Intelligence and Machine Learning. We are in an era in which most people cannot imagine living without either computers or smartphones. We…

Advances in the CRISPR-Cas9 system and gene therapy - Volume 32, Issue

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to…

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…

Medical Communications and Writing for Patients - Volume 33, Issue

Section Editor: Lisa Chamberlain James Encouraging vaccination through clever and abstruse incentives Author: Yannick Borkens The COVID-19 pandemic kept the world on tenterhooks for several years beginning in 2019. Well over 7 million people had…

President’s Message - Volume 33, Issue

See you in Valencia… Time is flying. We just left the autumn conference and now are approaching our main EMWA event – the spring conference, to take place May 7– 11, 2024. This time we go to Valencia, and I am sure that no one needs to be…

Psychotropics: A scientific, regulatory, and public view on the medicinal uses of cannabinoids and psilocybin - Volume 32, Issue

Research on psychotropics is gaining more popularity worldwide and support from drug regulatory agencies, which recognise the unmet medical needs of certain patient communities, such as patients with mental disorders and patients with cancer who…

Pharmacovigilance - Volume 31, Issue

The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…

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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.

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