Regulatory initiatives for artificial intelligence applications: Regulatory writing implications - Volume 32, Issue

Applications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to…

Transparency and the healthcare industry: The Sun is shining - Volume 22, Issue

The demand for greater transparency in financial relationships between the healthcare industry and healthcare professionals is increasing globally, and has led to establishing government regulations and professional guidelines for detailed reporting…

A decade of change: A new ISMPP has arrived - Volume 22, Issue

Founded originally as a not-for-profit society to provide education, advocacy, and best practices for those involved in medical publication planning, the International Society for Medical Publication Professionals (ISMPP) has grown in size to over…

Position Statement - AMWA-EMWA-ISMP Joint Position Statement on Medical Publications, Preprints, and Peer Review - Volume 30, Issue

In medical publications, just as in research and development, quality depends on the expertise and integrity of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and time-consuming process of the…

Message from the President - Volume 23, Issue

As my 1-year term as the EMWA president is ending, I would like to say that it has been a great year! Manchester and Barcelona were incredible successes. The Executive Committee is working hard to improve all aspects of the EMWA, and, thanks to…

Regulatory Matters - Volume 34, Issue

Section Editors: Clare Chang, Zuo Yen Lee

The AI-enabled medical writer: A new era for regulatory writing

Authors: Jenni Pickett, Vanessa de Langsdorff

As artificial intelligence (AI) becomes increasingly integrated into the pharma ceutical indust…

Out On Our Own - Volume 24, Issue

None of us like to think of getting older, and retirement may seem like a long way off for many. However, planning for your pension is critical if you want to ensure greater financial freedom without the need to take on so much work later in life.…

Out On Our Own - Volume 22, Issue

Editorial We hope that you enjoyed the summer months and found time to step away from your desks and relax. This time last year, Kath organised her first ‘Medical Writers’ Retreat’, the aim of which was to provide an opportunity for fellow…

EMWA News - Volume 29, Issue

The EMWA Executive Committee and Head Office closely monitored the rapidly evolving implications of the current COVID-19 situation and the recommendations from the World Health Organization as well as the advice from and restrictions implemented by…

History of biostatistics - Volume 25, Issue

The history of biostatistics could be viewed as an ongoing dialectic between continuity and change. Although statistical methods are used in current clinical studies, there is still ambivalence towards its application when medical practitioners…