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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…

Preparing the Paediatric Investigation Plan application - Volume 21, Issue

In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP…

Genetics and environmental factors in obesity and diabetes: Complex problems, complex solutions - Volume 21, Issue

Over the centuries people have become taller, heavier, and stronger. One of the major reasons for this is the increasing supply of calories in our diets. In earlier times, weight gain was extremely beneficial for health, well-being, and lifespan,…

The Webscout - Volume 22, Issue

Public health funding constitutes a big part of European social systems' expenditures. Governments and health insurance companies are thus interested in reducing spending. Applying pricing initiatives to innovative products confronts pharmaceutical…

Message from the President - Volume 22, Issue

Dear colleagues Time really does fly when you're having fun: I'm writing my third message since becoming EMWA President in May! The 37th EMWA Conference in Barcelona was an exciting event in a great location. We welcomed 102 new members, and 240…

The Webscout - Volume 22, Issue

There are different definitions of the adjective ‘good’, e.g. morally excellent; satisfactory in quality, quantity or degree; of high quality; excellent; well-behaved; etc. as the web dictionary tells us. In ‘good pharma’ the meaning of ‘good’ is…

Is cancer preventable? A literature review - Volume 21, Issue

Despite significant progress in tumour diagnosis and treatment over the last few years, cancer remains a major cause of death worldwide. Cancer prevention through diet and lifestyle changes is gaining importance, as our understanding of the…

The Crofter: Sustainable Communications - Volume 32, Issue

Rising to the challenge of sustainability in healthcare communications Climate change is among the greatest global challenges facing humanity, and although progress on tackling the issue is slow, the pharmaceutical industry is taking it seriously.…

Capitalising on social media marketing to raise confidence in COVID-19 public health information and vaccines - Volume 30, Issue

Widespread misinformation about COVID-19 has incited harmful behaviour that has undermined the public health response to the global pandemic, and posed a major threat to public health. To our detriment, social media has contributed to the spreading…

In this issue… The Medical Writing Business - Volume 24, Issue

As medical writers, we strive not just to survive but to thrive. Threats, opportunities, and complications come from many directions, and how to best position ourselves, our departments, and our companies requires much thought. Money is important…

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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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