Editorial - Volume 32, Issue

Unsung heroes: The medical writer’s role in clinical trials The medical writer is heavily involved in clinical trials from A to Z and even beyond. Although we are not in the frontline, our role is nevertheless crucial as we develop most of the…

Medical Writing in Japanese: Writing medical documents in English while thinking in Japanese - Volume 33, Issue

A medical writing primer for oncology dossiers - Volume 31, Issue

Oncology is one of the most common areas of drug development in the pharmaceutical industry. As a medical writer, it is important to be aware of the unique aspects of oncology studies and have some understanding of the principles underlying cancer…

Value of medical writing: The regulator's perspective - Volume 31, Issue

In 2020, the American Medical Writers Association established a working group to assess the value of the contribution of medical writers across the health sciences industry, including a subgroup tasked to gather data on the regulatory agency’s…

Medical Writing Around the World in 2024 - Volume 33, Issue

EMWA News - Volume 31, Issue

Medical Writing. 2022;31(4)10-11.

EMWA News - Volume 32, Issue

Medical Writing. 2023;32(2):10–11.

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…

Home office: Yay or nay? - Volume 31, Issue

In the first quarter of 2022, Bioforum performed an anonymous internal survey among its medical writers to understand if our employees would like to return to a physical office or prefer to stay in the home office despite the lifting of most of the…

News from the EMA - Volume 31, Issue

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…