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The increased prevalence of healthcare-related social media and other web-based communications has generated interest in tools that measure the attention and engagement of published content. In the context of medical research publications, the use…
One key point in 2012 to the Good Pharma - covigilance Practices (GVP) guidelines was mandatory consultation of all stakeholders before the first publication of GVP and after its implementation. Execution of these guidelines was influenced by public…
The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…
Model-informed drug development (MIDD) approaches maximise and connect information obtained on a drug during development, allowing better characterisation of its risk: benefit profile. MIDD is especially useful for rare diseases with few patients to…
Section Editor: Payal Bhatia EMWA’s medical device expert seminar series brings together speakers with different expertise providing valuable insights into the medical device industry. Medical device Expert Seminar Series: Beyond traditional…
The 6th EMWA symposium day will focus on medical devices in general, the recent changes in the European legislations, and opportu - nities for medical writers. The symposium is for regulatory writers and medical communi - cators alike, and will…
The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…
The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial…
The move towards patient engagement and patient involvement in healthcare decisions (“shared care”) has triggered a raft of new guidances from regulatory authorities, accompanied by new regulations mandating that pharmaceutical companies engage with…
The Chinese pharmaceutical regulatory landscape and medical publication policies have gone through drastic changes in recent years, and they continue to evolve. These changes provide great opportunities and many challenges to medical writers in…
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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