RCTs: Can the treatment work? Patient registries: Does the treatment work? - Volume 26, Issue

The first part of this article compares the main features of studies based on patient registry data with those of randomised clinical trials, providing a basis for better understanding the differences between the two. The second part details how to…

Regulatory Writing: Authorship issues in regulatory documents - Volume 25, Issue

When medical writers discuss authors and authorship – the theme of this issue of medical writing – they are usually referring to documents in the public domain such as journal articles or maybe congress abstracts. The primary purpose of such…

Message from the President - Volume 21, Issue

Dear Medical Writers Top of Form Bottom of Form I expect I am not the only one who at this time of year looks at their calendar in disbelief and asks how on earth another 12 months can have disappeared so quickly? The end of the year is always an…

Early benefit assessment of new drugs: The impact on healthcare in Germany - Volume 30, Issue

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…

Translating medical reports: Challenges and quality assurance - Volume 33, Issue

This article discusses the challenges and quality assurance measures implemented by the authors when translating medical reports. In particular, the authors discuss the challenges posed by acronyms, handwritten and scanned text, and desktop…

Regulatory Writing Basics - Volume 23, Issue

Post-Approval Regulatory Writing - Volume 23, Issue

Regulatory Public Disclosure - Volume 29, Issue

Activities around clinical documents disclosure have been slow since September 2018 when I last published this section. As many of you receive emails from the CORE Reference website (sign up at https://www.core-reference.org/subscribe), you have…

Regulatory Public Disclosure - Volume 33, Issue

Section Editor and Author: Sam Hamilton   Medical Writing. 2024;33(3):95–100. https://doi.org/10.56012/vhdv1639

Message from the President - Volume 23, Issue

As my 1-year term as the EMWA president is ending, I would like to say that it has been a great year! Manchester and Barcelona were incredible successes. The Executive Committee is working hard to improve all aspects of the EMWA, and, thanks to…