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The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…
An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…
Section Editors: Zuo Yen Lee, Clare Chang I did it so you don’t have to: Lessons learned as a young writer struggling with a regulatory document Author: Tiago Silva Medical writing is not easy, especially for new writers still learning the ropes.…
Regulatory documents are complex beasts, often requiring input from many different authors. Sometimes, different departments will be responsible for authoring certain sections and the role of the medical writer could perhaps be more accurately…
The role of a regulatory writer is to produce regulatory documents (usually taken to refer to documents that are submitted in some form to the health authorities). These documents should adhere to the relevant guidance and be fit for purpose, meani…
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…
The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…
Drug product developers and sponsors face a number of problems when organising a nonclinical study in Russia, especially, the diverse range of standards and few certified animal breeding centres, complicating adaptation of the available experimental…
NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…
Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and…
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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