Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse effects. High-quality safety databases, which store data on adverse events, drug reactions, medication errors, pregnancy, and special situations, are central to pharmacovigilance. These databases are essential for effective pharmacovigilance activities, including signal detection, risk assessment and management, and regulatory reporting. Data quality is paramount; errors in data entry and underreporting can significantly impact the accuracy and reliability of safety assessments. Accurate and well-managed databases enable robust and conclusive analyses to be performed, supporting regulatory decision-making and ensuring patient safety.

Evidence derived from real-world data is invaluable for expanding knowledge about medicines. As medical writers, we need to understand how to think about, handle, and communicate these data to ensure that they are credible and have a meaningful impact. This article shares what we have learned and what we wish we had known when we began working with real-world data.

Post-market clinical follow-up (PMCF) is a mandatory, ongoing process under EU MDR 2017/745, aimed at ensuring the continued safety and performance of medical devices. This manuscript outlines the regulatory requirements, methodologies, and integration of real-world data (RWD) in PMCF activities. It highlights how manufacturers can use RWD from registries, retrospective studies, and user surveys among other sources to fill clinical evidence gaps and support regulatory compliance. Case studies illustrate practical applications of RWD in PMCF. A systematic and data-driven PMCF approach is essential for effective post-market surveillance and the protection of patient health.

In recent years, the healthcare industry has experienced an exponential growth in the volume of real-world data (RWD) due to advancements in digital health, electronic health records (EHR), wearables, and other data-generating technologies. The integration of artificial intelligence (AI) and machine learning (ML) into real-world evidence (RWE) generation has the potential to revolutionise how clinical and healthcare decisions are made. AI and ML can effectively analyse large and complex datasets, identifying patterns and insights that were previously hidden or too difficult to detect using traditional analytical methods. For medical writers involved in regulatory submissions, clinical research documentation, and healthcare communications, understanding the application of AI and ML in RWE generation is essential. This publication explores the impact of AI/ML on RWE, its regulatory considerations, and best practices for integrating AI-driven insights into medical writing.

The clinical research landscape is constantly evolving, as new regulations and innovations come together to help accelerate scientific discoveries and medical advances. A prominent example of this is the rapidly emerging technology of artificial intelligence (AI). Using AI to develop lay summaries (LS) of clinical trial results can enhance transparency and accessibility, while maximising efficiencies and facilitating scalability. This document is a product of collaboration between experts from over 15 organisations in the US and the EU, including industry, academia, and a patient-focused nonprofit. It aims to explore how AI can be responsibly applied to LS development. While aligning with current industry standards, this document provides several recommendations for AI implementation that highlight the necessity of human oversight and expertise. This joint effort between human and machine can help LS achieve high standards in accuracy, transparency, and compliance, while building public trust and empowering patients to make informed healthcare decisions.

n atient authorship is where patients or caregivers are listed as byline authors of peer-reviewed publications. 1,2In such cases, the patients or caregivers, collectively referred to as "patient authors", have played a meaningful role in producing and sometimes even leading the publication.This is common for publications where patient or caregiver experiences, needs, or expectations are described or where having a person with lived experience adds important perspective, such as in rare diseases, where clinici ans and researchers may have limited knowledge.Patient authorship is being encouraged by patient advocacy groups, healthcare professionals, medical journals, academic institutions, pharmaceutical companies, and regulatory and health technology assessment agencies. 1,3,4As patient authorship of publications becomes more common, medical writers are more frequently being asked to collaborate with and support patient authors. Who are patient and caregiver authors of company-sponsored publications and what do they need?Increasingly, patients and caregivers are engaged in the work leading up to publication of company-sponsored research.For example, they may contribute to the design and conduct of the research 5 or may participate in publication steering committees. 6In some cases, however, patient authors are brought in to lend their perspective only once writing starts.In the worst cases, they are added only to increase the credibility of a publication, also known as "tokenism". 7atient authors of company-sponsored publications are often experienced patient advocates or leaders of patient organisations; some may even be researchers or clinicians themselves.In other cases, patient authors may have little experience in and knowledge of medicine or publications.Whatever their circumstances, patient authors are emotionally invested in helping to advance knowledge about a disease or condition affecting them or someone they care for, so they want to ensure their perspective is considered.

Medical writing is a global discipline, and its visibility is currently limited.While medical writing is a well-established career in central and southern Europe, it is an emerging profession in the Nordics and eastern Europe.The information on medical writing employers across Europe is limited online.Therefore, we conducted a survey in late 2023 to address this knowledge gap and provide a resource for experienced and aspiring medical writers alike.This article provides an overview of the types of organisations in which medical writers work across Europe.

Patient and public involvement and engagement (PPIE) in clinical trial design, conduct, and reporting provides an opportunity for patients and members of the public to provide input on what is important to them. This supports patient-centric trial design, more efficient trial conduct, and more transparent trial reporting. Patient input can enhance the trial’s purpose by ensuring the trial’s goals are meaningful and relevant, can allow exploration of the barriers and facilitators of compliance and adherence, improving recruitment and retention, and can ensure that studies address real-world issues. Medical writers can support the communication of PPIE activities across the clinical trial lifecycle through clear and effective writing.