The Webscout - Volume 26, Issue

Observational studies are better than their reputation. They have their place in the continuum of clinical research. The following recommended reading will give you an overview of the types of observational studies and their role.

Regulatory Public Dislcosure - Volume 32, Issue

In this information-packed edition of Regulatory Public Discussion, Sam Hamilton provides detailed comparisons of regulatory templates and updates on processes for the Clinical Trials Information System. Contributor: Sam Hamilton (author and…

Translation Section - Volume 21, Issue

Quality matters in medical translation In recent years, ‘translation quality’ has become a buzzword in the translation industry. Particularly since the introduction of European standard EN 150381 in 2006 and the certification process that has come…

Regulatory Writing: The essence of regulatory writing as defined by its jargon - Volume 23, Issue

In this issue of Medical Writing dedicated to regulatory writing, many of the articles provide some glimpses of the day-to-day problems and dilemmas faced by regulatory writers. It is hard, however, to describe the essence of regulatory writing in a…

News from the EMA - Volume 32, Issue

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…

Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

Regulatory Writing - Volume 23, Issue

Regulatory documents are complex beasts, often requiring input from many different authors. Sometimes, different departments will be responsible for authoring certain sections and the role of the medical writer could perhaps be more accurately…

Medical Education - Volume 25, Issue

Regulatory Public Disclosure - Volume 27, Issue

Welcome to Medical Writing’s first regular section on regulatory public disclosure (RPD). In this fast-evolving area, individuals can feel it’s almost impossible to keep up with developments.

Regulatory Public Disclosure - Volume 28, Issue

In the world of regulatory public disclosure (RPD) things rarely stay the same for long. This regular RPD section in Medical Writing and EMWA’s RPD SIG help you keep up.