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More than 30 years after the discovery of the human immunodeficiency virus as the agent that causes AIDS, an effective vaccine against this deadly disease has yet to be developed. The pathway to the development of a vaccine has been riddled with…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising…
Prior to this project, no patient lay summary (PLS) had ever been developed locally in Japan. In order to create a PLS that is more tailored to local patients, we attempted to develop one in and for Japanese. Such PLS was drafted based on the…
In our daily work in a company or freelance setting, we interact with other relevant functions, typically biostatistical, medical, programming, and data management colleagues, so that we can deliver wellrounded deliverables that take account of…
The Chinese pharmaceutical regulatory landscape and medical publication policies have gone through drastic changes in recent years, and they continue to evolve. These changes provide great opportunities and many challenges to medical writers in…
Business models in the field of medical and regulatory writing – can you think of a more suitable topic for discussing: collaboration, team working, and sharing complementary skills across different native languages? In this issue of Medical…
Ethical and evidence-based medical communications are gaining increasing importance in emerging pharmaceutical markets, outside of North America and Western Europe. In large pharmaceutical companies resources are limited, and small and mid-sized…
CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…
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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