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Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

Medical Device Regulation: A necessary step towards more patient and user safety - Volume 26, Issue

Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…

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…

Medical education in a medcomms agency - Volume 25, Issue

Medcomms agencies provide services and counselling to pharmaceutical clients in many ways. Medcomms are currently strengthening medical education as a form of indirect communication strategy, which focuses on educating health professionals on…

On educating the medical writer - Volume 22, Issue

Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

Educating the medical writer: A 5-year update - Volume 28, Issue

This article is a 5-year follow-up to a 2013 publication: On Educating the Medical Writer. The current study was performed to examine the evolution of degree programme titles, certificate programmes, and the current trend toward so-called…

Patient education in clinical trials and throughout the product lifecycle - Volume 25, Issue

Good patient education supports improved outcomes and an efficient, cost-effective healthcare system. In the highly regulated, fast-paced pharmaceutical industry, the challenges that medical writers face in writing for patients are multi-fold.…

News from the EMA - Volume 29, Issue

September 14, 2020 – The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020–2021. With the European Medicines Regulatory Network focused on the…

Allergen immunotherapy in the European regulatory environment - Volume 27, Issue

Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a…

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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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