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Some considerations on the safety evaluation section of clinical study reports for studies with anticancer drugs - Volume 21, Issue

The International Conference on Harmonisation (ICH) guideline E3 describes the structure and content of clinical study reports (CSRs). However, this standard structure should be interpreted according to the type of study and data, including…

The Crofter: Sustainable Communications - Volume 33, Issue

Section Editors: Louisa Ludwig-Begall, Sarah Kabani How close are we to sustainability? Author: Catarina Leitão I have always loved nature. When I was a kid, I preferred watching wildlife documentaries to cartoons. Those documentaries taught me…

Mentorship - Volume 30, Issue

Mentorship is a topic very close to my heart. If it were not for the numerous mentors in both my academic and professional life, I would not be here today. The definition of mentorship is subjective and how a mentor operates is often up to those…

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

Lingua Franca and Beyond - Volume 25, Issue

In this issue of Medical Writing, I would like to recommend two articles. Szymon Musiolshares with us his thoughts on a statistician’s role in research overall and also in the process of preparing publications. He takes a medical writer’s…

Measuring health outcomes: The foundation of contemporary healthcare decision-making - Volume 27, Issue

Healthcare professionals and patients are (or should be) interested in understanding the benefits of health care. We should be able to know the expected treatment benefits and to see quantifiable evidence that supports those expectations. Such…

Regulatory pathways for development and submission activities - Volume 28, Issue

This article discusses how different regulatory requirements for a dossier requesting marketing authorisation for a medical drug affect the deliverables from development functions and the submission groups including medical writing. The content of…

Working with authors to develop high-quality, ethical clinical manuscripts: Guidance for the professional medical writer - Volume 23, Issue

One measure of career success for clinical researchers is reporting their findings in a peer-reviewed journal. Writing a clinical manuscript that has impact and relevance to their intended audience is crucial for publication success. However,…

Global and multidisciplinary perspectives on collaboration with medical writers - Volume 33, Issue

Medical writers, document quality reviewers, and document specialists work together to produce high-quality clinical and regulatory documents. Cross-functional collaboration with other functional leads like bio statisticians, medical monitors, and…

EMWA’s Special Interest Groups (SIGs) - Volume 26, Issue

The EMWA SIGs allow EMWA and its members to contribute to important conversations around topics that we know will impact on our industry in the coming years. You may have colleagues interested in joining the EMWA SIGs to debate, and share best…

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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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