New EU medical device regulations: Impact on the MedTech sector - Volume 26, Issue

Abstract Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single…

Regulatory Matters - Volume 29, Issue

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 28, Issue

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

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…

Regulatory Writing - Volume 22, Issue

The recent publication of the book Bad Pharma by Ben Goldacre1 has caused quite a stir in the medical writing community (and indeed throughout the pharmaceutical industry).

Regulatory Matters - Volume 26, Issue

Medical writers are often involved in the preparation of submission documents such as clinical overviews and clinical summaries. The submission of the application (or, in the case of drugs already approved, a variation or supplement) is an important…

Regulatory Writing - Volume 21, Issue

The Physicians Payment Sunshine Act – casting a shadow over clinical research? In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their…

Regulatory Writing - Volume 21, Issue

The European Medicines Agency looks to the future At the end of 2010, the European Medicines Agency (EMA) published a road map that laid out a ‘strategic vision for the operation of the European Medicines Agency’ from 2011 to 2015.1 According…

Regulatory Writing - Volume 22, Issue

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…

Regulatory Matters - Volume 28, Issue