Real-world data and evidence: A European regulatory perspective - Volume 34, Issue

The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from…

Towards electronic product information that meets the needs of everyone: Implications for patients, clinicians, and medical writers - Volume 34, Issue

In an age of increasing digitisation, pharmaceutical product information is evolving. This transformation reflects growing recognition among regulators of the value of patient engagement and widespread societal calls for increased transparency of…

Regulatory Writing - Volume 21, Issue

The discussion section of a clinical study report The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go…

Opportunities in veterinary writing - Volume 23, Issue

Unlike medical writing, ‘veterinary writing’ does not exist as a defined career path. However, writers are inevitably also required in this field and play important roles in different areas of the veterinary profession for creation of scientific…

REACH chemical dossiers? Yes, please! - Volume 23, Issue

Medical writing knowledge and skills can be applied relatively easily to other areas of technical regulatory writing, with a bit of home study. One such area is in the compilation and write-up of REACH (Registration, Evaluation, Authorisation, and…

The Write Stuff Archive

The Write Stuff Archive

The Write Stuff was the name of EMWA’s journal starting in 1998 and up until the name was changed to Medical Writing in 2012. This archive contains issues of The Write Stuff dating back to 2002.

Volume: 20 | Issue: 4 | Ye…

Regulatory Writing: Authorship issues in regulatory documents - Volume 25, Issue

When medical writers discuss authors and authorship – the theme of this issue of medical writing – they are usually referring to documents in the public domain such as journal articles or maybe congress abstracts. The primary purpose of such…

Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations - Volume 24, Issue

There is a paradigm shift in the pharmaceutical industry and regulatory agencies towards transparency and an emphasis on the benefit-risk ratio of medicines. The recent changes in legislation surrounding clinical documentation have produced…

Effective authoring of clinical study reports: A companion guide - Volume 23, Issue

‘Why write a clinical study report (CSR)? What are the guidance documents? Can I interpret them? Can I deliver my CSR on time?’ This article addresses these questions – and others, provides a companion guide to CSR authoring for preregistration drug…

The changing face of medical writing in India - Volume 22, Issue

Economic liberalisation has led to an influx of clinical research and a boom in the medical writing industry in India. Medical writers in India at present contribute mostly to medical communications, health journalism, and academic medical…