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Ongoing patient engagement research efforts at the Centre for Pharmaceutical Medicine Research, King’s College London - Volume 34, Issue

Research efforts within the Centre for Pharmaceutical Medicine Research, King’s College London, are advancing patient engagement in medicine development and communications through evidence generation. This article presents the ongoing work of two…

Preparing the Paediatric Investigation Plan application - Volume 21, Issue

In Europe, sponsors must possess a compliant Paediatric Investigation Plan (PIP) when applying for marketing approval of drugs. The core deliverable is the ‘scientific part of the application’ structured according to the EMA's PIP guideline. The PIP…

HTA decision-making: Do ethics matter? - Volume 30, Issue

Before reviewing the article in this issue of Medical Writing by Larry Liberti and Tina Wang, The regulatory-HTA decision-making interface: What the medical writer should know (p. 50), I put on my ethicist’s hat. Thus, I tuned my ethics antennae to…

How FAIR are pharma publication data? - Volume 31, Issue

Sharing research data increases reusability, reduces waste, supports reproducibility and promotes innovation. In medical research, sharing data also promotes transparency and access to information relevant to patient care. While important…

A survey on current use of software tools for systematic literature reviews - Volume 32, Issue

Adoption of the EU Medical Devices Regulations and In Vitro Diagnostics Regulations has led to increased demand for systematic literature reviews. This article reports on a survey investigating the current use of software platforms and tools by…

Protection of personal data and commercially confidential information under the Clinical Trials Regulation (EU) No. 536/ 2014 – EMA “Revised CTIS Transparency Rules" - Volume 33, Issue

The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…

Out On Our Own - Volume 21, Issue

After a wonderful May spring week in sunny Cyprus – it was good to see so many of you at the Freelance Business Forum (FBF) – it's back to business as usual with a packed issue. The FBF minutes summary has not made it into this issue due to print…

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

English Grammar and Style - Volume 25, Issue

Good Writing Practice Writing abstracts for congresses (2) Tables and Figures Unlike manuscript abstracts, congress abstracts may often include tables or figures, or both. Many congresses allow these to be submitted alongside the abstract text,…

Erratum - Volume 23, Issue

The WebscoutKarin Eichele http://journal.emwa.org/regulatory-writing-basics/the-webscout/ We would like to acknowledge an error in the above section in Vol. 23 No. 2. The correction has been made to the online version of the article. The…

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Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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