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Ingrid Edsman, with 17 years of increasingly senior clinical research positions in the Pharmaceutical Industry, is an expert in the preparation of regulatory and clinical documents. She obtained a Medical Degree at the Karolinska Institute in…
Drug development forms the core of the pharmaceutical industry. Medical writing is a key function in pharmaceutical companies and clinical research organisations that works on scientific publications and regulatory dossiers. Regulatory writing…
Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…
Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
Designing clinical trials in rare diseases comes with a specific set of challenges including limited knowledge around the natural history of a disease, small sample size available for trial participation, regulatory guidance that is not calibrated…
Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…
Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…
Artificial intelligence and digital health open a new chapter in the pharmaceutical industry. The digital technologies improve work efficiency, lower research and development costs, optimise medical research processes, and increase R&D outputs.…
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…
Like many medical writers, I started in another career first. For me, it was practising veterinary medicine in a clinic, then going into clinical research in humans, and then on to medical writing. Designing clinical trials, sample size…
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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