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The use of vaccines and immunotherapies in medicine dates back to the end of the 18th century and the work of Edward Jenner, the father of immunology. Jenner, building on the observations of John Fewster in 1768, showed that inoculation with the…
Patient and public involvement and engagement (PPIE) in clinical trial design, conduct, and reporting provides an opportunity for patients and members of the public to provide input on what is important to them. This supports patient-centric trial…
Anuradha Alahari (section editor) EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…
Developing drugs for cancer is a process as complex as the disease itself. At the planning stage of a clinical trial for an oncology drug, thorough and careful consideration must be given to choosing the right study design and endpoints/estimands,…
Science communication plays an important role in educating the public about scientific knowledge. Until recently, publishing in research journals and presenting at science conferences were the only options available to scientists for sharing their…
The past two years have confronted humanity with a variety of unprecedented challenges due to the far-reaching COVID-19 pandemic. In response to this tragedy have come monumental new advances in science and technology – namely the vaccines developed…
EMA is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles replace, reduce and…
The more eagle eyed among you will have noticed that we are changing the title of this section to “Medical Communications and Writing for Patients”. Not the shortest of titles, I know, but hopefully it is a more accurate reflection of the content…
A year of EMWA firsts has passed and while we are still not in a post-pandemic phase, one can see that our profession has regained its momentum. In the past, you might have experienced the need to explain to family members and friends what “medical…
The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is…
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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