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Dear EMWA Members,The time has been passing so quickly, with 2017 coming to an end and the holiday season now upon us.I am sure we all have enjoyable memories of our very successful conference in beautiful Cascais. Since my last message, the…
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…
I am the founder and managing director of Scinopsis, a medical writing company based in France. Scinopsis is specialised in providing regulatory documents and medical communications to the pharmaceutical, biotechnology, and medical device…
Unlike medical writing, ‘veterinary writing’ does not exist as a defined career path. However, writers are inevitably also required in this field and play important roles in different areas of the veterinary profession for creation of scientific…
Analysis of statistical data is an important part of any medical writer’s skill set, especially those professionals working in publication and regulatory areas. Under - standing the various study designs is key to a thorough understanding of study…
In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and…
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…
Most medical writers received their education on the job rather than through formal education. These writers may have gaps in knowledge when compared with lists of competencies published by professional organisations in the clinical research and…
Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that…
The International AIDS Vaccine Initiative (IAVI) is a global scientific and advocacy organisation dedicated to ensuring an AIDS vaccine for use worldwide. In Africa, IAVI partners with seven research centres who conduct vaccine trials and studies.…
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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