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…

The horror and the pity: Obesity and diabetes - Volume 21, Issue

Something less beguiling for a horror-story addict than the emergence of obesity would be hard to imagine. Start by reading the 27 August 2011 issue of the Lancet. One article predicts that the obesity rate in the UK will make the tremendous leap fro…

President's Message - Volume 30, Issue

After several lockdowns, “everyday” life is beginning to return, although COVID-19 continues to be a destructive force in many parts of the world. In Germany, where I am currently located, COVID-19 cases have been rather low (with occasional…

The war on cancer – What is the enemy, and are we winning? - Volume 21, Issue

The so-called ‘war on cancer’ is now in its fifth decade. This article presents some facts and figures about cancer and the effort to treat it. It outlines updated thinking on the hallmarks and classification of cancer, and draws together published…

Post-approval regulatory writing - Volume 23, Issue

Anonymisation reports from 2016 to 2017: A preliminary analysis - Volume 27, Issue

The anonymisation report (AR) is a new and  relatively unknown regulatory document,  submitted as part of the redacted package of  a marketing authorisation application under  the EMA Policy 0070. The report documents  the methodology of…

Risk management plans in the EU: Managing safety concerns - Volume 29, Issue

The preparation of pharmacovigilance documents is related to ongoing activities during the life cycle of a medicinal product and encompasses crucial processes beyond writing: strategic planning and inter disciplinary work in the context of…

Advances in the CRISPR-Cas9 system and gene therapy - Volume 32, Issue

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 is a genome editing tool that helps scientists modify the DNA of living organisms selectively and precisely. The discovery of this system has led to changes in the approaches to…

Artificial Intelligence and Machine Learning - Volume 32, Issue

Guest Editors Daniela Kamir and Shiri Diskin provide an introduction to this issue, whose theme Artificial Intelligence and Machine Learning. We are in an era in which most people cannot imagine living without either computers or smartphones. We…

Making the leap: Transparency requirements for clinical trials moving from one regulatory framework to another - Volume 33, Issue

This article discusses the fast-approaching deadline for sponsors to transition ongoing clinical trials in the EU/European Economic Area from the Clinical Trials Directive 2001/20/EC to the Clinical Trials Regulation 536/2014. In particular, the…