Transparency through the lens of data protection and privacy: A clinical research organisation medical writing perspective - Volume 33, Issue

Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community - Volume 33, Issue

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conduct…

Non-clinical health writing - Volume 23, Issue

We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…

Post-approval regulatory writing - Volume 23, Issue

Medical writing in the era of artificial intelligence - Volume 28, Issue

The increasing amount of data available together with advances in computer science are converting computers from simple tools that execute commands into self-taught, self correcting machines that make decisions. This is the beginning of the era of…

Elements of storytelling in medical journalism - Volume 24, Issue

Medical journalists marry the techniques of technical medical writing and storytelling in their work. They need a high-level understanding of the science behind the story, but they must also skilfully employ techniques that draw in readers who may…

Writing for mixed-media training programmes - Volume 25, Issue

Effective learning and development tools are important in spreading and consolidating knowledge within any pharmaceutical or biotechnology company. Medical communications professionals may be involved in creating training materials for many…

Writing for orphan drugs: A compass to navigate document types and regional requirements - Volume 34, Issue

Medical writing for rare diseases encompasses the development of various regulatory documents that are required to obtain orphan drug designation and marketing authorisation for treatments targeting rare conditions. Effective planning and close…

Navigating the complex landscape of clinical trial transparency: What medical writers need to know - Volume 33, Issue

Clinical trial transparency is beneficial for patients, researchers, and the general public. However, rapidly evolving regulatory requirements for transparency have increased the information that will be published. Medical writers can play a key…

Training and development opportunities for medical writers from different regions across the world - Volume 33, Issue

In the dynamic and rapidly evolving field of medical writing, continuous learning and professional development are crucial for success. Medical writers play a vital role in translating complex scientific and medical information into clear, accurate,…