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Social media and altmetrics: The pharma perspective - Volume 30, Issue

The increased prevalence of healthcare-related social media and other web-based communications has generated interest in tools that measure the attention and engagement of published content. In the context of medical research publications, the use…

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…

Medical writing for generics throughout the life cycle - Volume 28, Issue

Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…

Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

On the western edge of Europe – medical writing in Portugal - Volume 22, Issue

Within Portugal, medical writing is a new and rare profession. We describe our personal career routes to medical writing and discuss the barriers and the emerging opportunities for medical writers in Portugal. The profession of medical writing is…

Interview: A career journey in sustainability: Three questions for Alex Schuman, Head of Corporate Sustainability and Diversity, Equity and Inclusion, Schrödinger - Volume 31, Issue

Many pharmaceutical and medical device companies are making huge environmental, social, and governance (ESG) commitments, such as striving to achieve carbon neutrality, and aiming to reach diversity, equity, and inclusion (DEI) goals. In order to…

Landscaping the terminology of accessible language document types - Volume 31, Issue

There are three main types of accessible language documents that medical writers and medical publications professionals may work on. These are regulatory lay summaries, publication-associated plain language summaries (PLS), and standalone plain…

Peer review of a clinical trial protocol: Practical tips for regulatory medical writers, clinicians, and clinical scientists - Volume 32, Issue

Protocol development is a critical milestone in the clinical drug development process for all pharmaceutical companies conducting clinical trials. A regulatory medical writer (RMW) plays a crucial role in the protocol development and peer review…

Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee Briefing documents: Facilitating health authority interactions Author: Clare Chang Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities…

Writing for patients: When and how? - Volume 29, Issue

The move towards patient engagement and patient involvement in healthcare decisions (“shared care”) has triggered a raft of new guidances from regulatory authorities, accompanied by new regulations mandating that pharmaceutical companies engage with…

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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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