Immuno-oncology: Harnessing our immune system to fight cancer - Volume 27, Issue

The history of immunotherapy to treat cancer began in 1891 when the American surgeon William Coley performed intra-tumoural injections with inactivated bacteria in patients with advanced sarcoma, in an attempt to stimulate anti-tumour immunity.…

The Crofter: Sustainable Communications - Volume 30, Issue

Greetings from the croft! In this special issue on medical journalism, we have two contributions that discuss topics that have enjoyed attention in the press: 1. the emerging environmental problem because of the growing drug market for pets, and 2.…

Medical Communications and Writing for Patients - Volume 33, Issue

Section Editor: Lisa Chamberlain James

Involving patients in company-sponsored medical publications: Learning from collaboration with a patient advocacy group to engage patient authors

Authors: Aki Yoshikawa, Atsuko Iwata, Miho Hatano, Yuko Koji…

Outgoing President's Message - Volume 31, Issue

Dear friends, colleagues, and EMWA members, despite the global COVID-19 pandemic and the war in the Ukraine, EMWA’s financial situation and membership numbers remained stable over my term of presidency. In fact, membership numbers slightly…

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

The Crofter: Sustainable Communications - Volume 31, Issue

Greeting from the croft! During my non-linear career path, there has been one recurring theme that always rang true: “Context matters”. As a physical therapist working in a rehabilitation centre, understanding my clients’ social roles, home…

Someone in your corner: Musings of a mentor and mentee - Volume 30, Issue

What is a modern mentorship, how do you make it work, and what does gardening have to do with it? Let us take you on a tour of the growing garden of our own modern mentorship, showing how we as a medical writer (Lillian Sandø; mentor) and a clinical…

Writing reports of modelling and simulation analysis: Our experience in the field of pharmacometrics - Volume 32, Issue

Pharmacometric analyses generate mathematical models that can describe and simulate the pharmacokinetics and pharmacodynamics of drugs. The role of these modelling and simulation (M&S) analyses is growing both in drug development and regulatory…

Clinical trial disclosure: Perspective from a medical writer for a contract research organisation - Volume 28, Issue

In this article, I summarise how, as a medical writer with over 20 years of experience in regulatory writing, all with a contract research organisation, I transitioned into the world of disclosure and how I now have my feet firmly in both camps:…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

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…