Medical Writing Authors Jennifer Clemens

Jennifer Clemens


Regulatory Matters - Volume 29, Issue 4

Ever since the EMA mandate for plain-language summaries of clinical trials was codified in Clinical Trial Regulation EU No. 536/2014, medical writers have grappled with the task of making these documents accessible to the public, including to…

Regulatory Matters - Volume 29, Issue 3

Background for immunooncology studies - Accumulated research of more than a century has led to our current  expansive understanding of the vertebrate immune system as a complex, multi-functional, evolutionary unit: a diverse, powerful, and adaptable…

Regulatory Matters - Volume 29, Issue 2

Master trial documents for increased efficiency and scientific integrity.

Regulatory Matters - Volume 29, Issue 1

A medical writer’s perspective on the relationship between EMA Policy 0070 and the General Data Protection Regulation

Regulatory Matters - Volume 28, Issue 4

Using technology to reduce the time it takes to generate patient narratives

Regulatory Matters - Volume 28, Issue 3

Changes in the regulatory landscape and changes in our professional environment make this an exciting time to be part of the regulatory medical writing community. It is a time when new opportunities are presenting and when, like never before, the…

Regulatory Matters - Volume 28, Issue 2

Vignettes - Life After Medical Writing - Volume 28, Issue 1

Regulatory Matters - Volume 28, Issue 1

November 30, 2018 – EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revised guideline for haemophilia medicines for factor VIII deficiency…

Regulatory Matters & Regulatory Public Disclosure - Volume 27, Issue 4

A symbiotic relationship is an “intimate interaction between two or more species, which may or may not be beneficial to either”.1We can think of the bee and flower relationship. The flower provides the bee with nectar, while the bee provides…

Regulatory Matters - Volume 27, Issue 3

Nearly everyone remembers the childhood tale of The Wizard of Oz. Four characters searched for something they believed magic alone could create, only to find that they already possessed it. The image of the Tin Man comes to mind, who believed he did…


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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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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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