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This story may sound familiar. Having spent my entire career on the academic bench, I decided it was time for a change. I still want to use my brain, I still want to be a part of the biomedical sciences, but I am ready to put the pipette down for…
The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…
A year has passed so quickly and it is time for me to step down and hand over to Andrea Rossi, the new EMWA President and the first Italian to take on this important position. On reading through the various messages I sent you during the past year,…
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…
Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…
Medical writing plays an integral part in the pharmaceutical industry, be it for originator or generic drug companies. Most writers are working for medium to large research-based companies. However, even for generic drug firms many documents need to…
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…
Amidst the dynamic landscape of pharma - covigilance legislation, medical writers have been gaining increased visibility and importance beyond what had been their traditional role of coordinating and facil it - ating the development of risk…
We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
The freelance medical writing landscape has evolved in recent years, with more market demand for competent medical writers who can work on a project basis. In January 2023, the European Medical Writers Association’s (EMWA) Freelance Business Group…
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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