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Good regulatory practice and the role(s) of a regulatory affairs professional - Volume 22, Issue

Good Regulatory Practice is a regulatory affairs quality standard that is based on trained people who understand their professional role and work in an environment that follows standards and processes. This article illustrates the diversity of roles…

Veterinary regulatory writing in Europe - Volume 23, Issue

Regulatory writing for the veterinary pharmaceutical industry is in many ways similar to other types of regulatory writing, but there are also clear differences. This article outlines the veterinary regulatory structure in Europe and, in…

An introduction to medical affairs for medical writers - Volume 28, Issue

The role of medical affairs in pharmaceutical and medical device companies is gaining prominence. Medical writers will increasingly find themselves supporting medical affairs activities or, indeed, transitioning to jobs within medical affairs…

Medical affairs writing: A key role to relay medical information to everyone - Volume 25, Issue

Medical Affairs is a link between the scientific and marketing units of a pharmaceutical company. Medical writers in this field are responsible for writing varied document types from regulatory reports to scientific publications, and marketing…

The new PubMed – underestimated regulatory obstacles - Volume 29, Issue

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…

How mentorship has created a special community and helped people develop their careers - Volume 30, Issue

Mentorship is an extremely rewarding relationship between two people with the goal of professional and personal development. Elemed’s Mentoring Academy in partnership with the Regulatory Affairs Professional Society (RAPS) combines three pillars –…

EMWA News - Volume 25, Issue

A lot was going on from April to June this year. Certainly the main event was our spring conference in Munich. Aside the established workshops, Freelance Business Forum, Expert Seminar Series, and updates on Special Interest Groups – it included an…

Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations - Volume 24, Issue

Laura C Collada Ali wears different hats: she is a medical writer plus a medical translator, and has extensive experience delivering multilingual authoring and translation services across a wide range of independent research organisations. She is a…

Medical writing in the era of artificial intelligence - Volume 28, Issue

The increasing amount of data available together with advances in computer science are converting computers from simple tools that execute commands into self-taught, self correcting machines that make decisions. This is the beginning of the era of…

A PhD and medical writing: A good match - Volume 25, Issue

The transition out of academia can involve a good deal of change. For PhDs who enjoy writing, a career in medical communications is a viable option. The field of medical writing is broad, encompassing everything from regulatory affairs, to writing…

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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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