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The early benefit assessment of new drugs was introduced in Germany in 2011. The main rationale was to support pricing negotiations between the statutory health insurance (SHI) system and the pharmaceutical industry. The early benefit assessment…
A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…
Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…
Welcome to this special issue about nonclinical and preclinical research. Nonclinical and preclinical research is the first step toward new drug development, where scientists investigate mechanism of action, pharmacokinetics, and safety. Many…
The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…
Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…
In the recently published ‘Pharmaceutical Medical Writing Competency Model’, a group of medical writers describes the knowledge, skills, and behaviours they considered essential for successful medical writers. Thus, this model represents a list of…
The sharing of individual participant-level clinical data is now an almost routine extension of the clinical study life-cycle, and increasingly a vital element of leveraging real-word data. Responsible clinical study data sharing of appropriately…
Dear all,In this issue, Rossella Ferrari tackles the elephant in the room – how do medical writers manage to find time for their continuing professional development whilst still keeping their head above water with their ongoing project work?We all…
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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