Your search for "harmonisation" matched 173 page(s).
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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…
This feature explores the authors experience in supporting researchers in low- and middle-income countries (LMICs). After years of honing her skills in both basic research and medical writing, Julie Chaccour transitioned into a position in research…
The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…
The Regulatory Expert Seminar session at the 2021 Spring EMWA Conference took us on an amazing journey through marketing authorisation applications from a regulator’s and medical writer’s perspective. One of the presentations focussed on the…
With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors…
Dear EMWA Members, As you are well aware, we have been celebrating our 25th anniversary as an organisation and have sent out specially designed buttons with the December issue of Medical Writing to commem - orate the occasion. To continue the…
This paper describes the role of social media in healthcare and medicine based on the example of how a contract research organisation (CRO) uses video interviews to spread knowledge and expertise among professionals. Considering that in coming…
How does a team of medical writers working in different countries navigate different time zones and cultures to get their work done remotely? In this interview, a team of six medical writers and one editor working at P95, a private research…
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…
One of the main reasons why the Freelance Business Group (and the whole of EMWA as well) is thriving and growing is because of the number of our members who volunteer to carry out our activities and help in implementing new initiatives. Becoming a…
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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