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New EU medical device regulations: Impact on the MedTech sector - Volume 26, Issue

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…

Regulatory medical writing in Switzerland - Volume 22, Issue

Switzerland is practically unknown in the drug/medical device regulatory landscape despite being home to some of the world's biggest pharmaceutical firms. This article briefly describes the regulations governing clinical trials in Switzerland and…

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations - Volume 24, Issue

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…

Transparency and the healthcare industry: The Sun is shining - Volume 22, Issue

The demand for greater transparency in financial relationships between the healthcare industry and healthcare professionals is increasing globally, and has led to establishing government regulations and professional guidelines for detailed reporting…

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report - Volume 23, Issue

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of…

Staying ahead of the game in the changing arena of ethical medical communications - Viewpoint of a freelance medical writer - Volume 25, Issue

Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…

Writing publications for advisory boards - Volume 23, Issue

Medical communication publications are designed to raise awareness of medicines, cosmetics, and technology. These publications ensure that doctors are informed about the role of new and existing medicines and the literature concerning appropriate…

The evolving landscape of medical education in oncology - Volume 21, Issue

The field of oncology is continuously evolving. The way in which cancer is diagnosed, staged, and managed has changed so much in the last decade, and awareness of the need for a ‘personalized medicine’ approach to patient management is growing. In…

Good clinical practice (GCP): A universal call for ethics in biomedical research - Volume 23, Issue

Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…

Nanoapplications – From geckos to human health - Volume 23, Issue

Nanotechnology, the manipulation of matter on a molecular scale, is all around us in our everyday lives. Chocolate, non-dairy creamer, and sunscreen are examples of consumer products with a high content of nanoparticles. Nanotechnology holds great…

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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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