Can access and accessibility rebuild public trust in research? - Volume 31, Issue

Trust is built gradually, and it is easily threatened, particularly in relation to pharmaceutical research. The potential for open access publishing and plain language summaries to contribute to improved trust in pharmaceutical research was…

Reports from the spring EMWA conference. Expert seminar: Use of clinical study reports for Cochrane Reviews - Volume 27, Issue

Promoting equity in understanding: A cross-organisational plain language glossary for clinical research - Volume 29, Issue

Clear communication with the public and with potential clinical trial participants and their caregivers is foundational to the ethical tenets of respect, justice, and beneficence. However, health literacy, even of highly educated individuals, often…

Reveal, Rebalance, Release: Thoughts on mentoring young professionals in the industry - Volume 30, Issue

Making the first steps as a medical writer in the pharma and biotech industry can be challenging. Three general principles can help managers foster the growth and development of their team members: Reveal, Rebalance, and Release. Reveal means that…

How can coaching or mentoring help you craft a sustainable freelance career - Volume 32, Issue

Crafting a sustainable freelance MedComms career can be challenging. As freelancers, we need to understand our individual requirements to design and implement a freelance business that will work from a personal and a professional perspective.…

The yin and yang of medical writing in China - Volume 22, Issue

China is becoming a superpower in many areas, including the global medical literature. In this article, we describe medical writing in China, with a focus on efforts to enhance the yin (quality) and yang (quantity) of publications. Quality…

Building resilience: Navigating challenges and thriving among the demands of regulatory writing - Volume 33, Issue

Regulatory writing is a demanding yet rewarding profession in which writers help pave the way for groundbreaking healthcare innovations that improve the lives of patients. However, as critical as our work is, regulatory writing is full of challenges…

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers - Volume 29, Issue

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…

Artificial intelligence – will we be replaced by robots? - Volume 28, Issue

Advances in artificial intelligence (AI) increasingly dominate the news with billions of dollars in funding invested to combine AI with machine learning and data science across many disciplines, including medicine and healthcare. Within the context…

New documents required by the medical device regulation - Volume 29, Issue

This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…