Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…

Regulatory Writing - Volume 22, Issue

This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led…

The role of real-world evidence in post-market clinical follow-up - Volume 34, Issue

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…

Special section: Winners of the Geoff Hall Scholarship essay competition - Volume 24, Issue

The Geoff Hall Scholarships (GHSs) are given in honour of a former President of EMWA. Geoff was a very special person, an extremely valued member of EMWA, and a very good friend to many EMWA members. He firmly believed that the future of EMWA lies in…

Defining the quality of data within rare disease registries: A systematic review - Volume 34, Issue

Rare diseases have a low prevalence within society, resulting in limited awareness and challenges with data availability for research. While rare disease registries offer valuable data, ensuring quality of the data is essential. This review explores…

Lessons learnt from PETHEMA’s RWD research: A clinical perspective - Volume 34, Issue

PETHEMA (Programa Español de Tratamientos en Hematología, or, Spanish Program for Treatments in Haematology) a leading cooperative group in haematological research, has increasingly integrated real-world data (RWD) as a complement to traditional…

From data to impact: Exploring the evolution of real-world evidence at the FDA - Volume 34, Issue

The healthcare industry has witnessed a significant shift towards the use of real-world data (RWD) and real-world evidence (RWE) in medical decision-making and treatment evaluation. This article explores the importance of RWE in healthcare…

Challenges of paediatric drug development and impact of paediatric legislation - Volume 21, Issue

Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…

Message from the President - Volume 22, Issue

A year has passed so quickly and it is time for me to step down and hand over to Andrea Rossi, the new EMWA President and the first Italian to take on this important position. On reading through the various messages I sent you during the past year,…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…