News from the EMA - Volume 23, Issue

Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data   From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…

Writing for pharmaceutical or medical device companies: A survey of entry requirements, career paths, quality of life, and personal observations - Volume 25, Issue

The spectrum of medical writing activities across the pharmaceutical and device industries is vast. We conducted a limited survey of medical writers predominantly working in industry or for agencies to learn of their personal and professional…

EU Regulations - Volume 29, Issue

Out on Our Own - Volume 25, Issue

In this edition of OOOO, we are pleased to bring to you four diverse and thought provoking articles, and some practical tips. We thank you for your contributions and once again invite you to submit any articles that you wish to share with your…

The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance - Volume 23, Issue

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…

Journal Watch - Volume 21, Issue

Impact of protocol amendments, bias and quality in industry-funded trials, and rethinking authorship criteria Amendments to clinical trial protocols are widespread, but can result in increased costs and delays in study implementation.

The Webscout - Volume 24, Issue

The word ‘plain’ in its original sense just meant ‘flat, smooth’. In the thirteenth century, it also gained the meaning ‘evident’. And from the fourteenth century on, ‘plain’ has been used in the way we understand it in the term ‘plain language’: to…

Getting Your Foot in the Door - Volume 26, Issue

On internships, scribes, and work experience.For this edition of GYFD, I would like to provide some background information about internships, including the history of the term and answers to some frequently asked questions about it. The objective is…

Getting Your Foot in the Door - Volume 25, Issue

Welcome to Getting Your Foot in the Door or GYFD for short, the latest addition to MEW’s regular sections. It all started at the EMWA 2015 autumn meeting in The Hague. Derek Ho met up with the EMWA Executive Committee (EC) to talk about his idea of…