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The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers…
Ruggero Galici is Senior Director of Nonclinical and Clinical Pharmacology Medical Writing at Alexion Pharmaceuticals Inc, AstraZeneca Rare Disease Unit and heads up global early phase regulatory medical writing activities. In this role, he…
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…
The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…
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.…
The Physicians Payment Sunshine Act – casting a shadow over clinical research? In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their…
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…
Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…
Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants –…
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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