EMWA News - Volume 30, Issue

AMWA-EMWA-ISMPP Joint Position Statement on Medical Publications, Preprints, and Peer Review The AMWA-EMWA-ISMPP Position Statement on Medical Publications, Preprints, and Peer Review, published in Current Medical Research and Opinion (CMRO),…

Preparing clinical study reports for external sharing - Volume 27, Issue

As the EMA refines its requirements for the external publishing of clinical study reports, the workload of medical writing teams is increasing to include robust processes for clinical study report anonymisation. Until now, life sciences firms have…

Regulatory submissions of non-interventional post-authorisation safety studies - Volume 26, Issue

The post-authorisation safety study (PASS) is a pharmacovigilance activity often required as a post-marketing commitment to establish a safety profile or address specific safety concerns. An imposed PASS must be submitted in common technical…

Artificial intelligence – will we be replaced by robots? - Volume 28, Issue

Advances in artificial intelligence (AI) increasingly dominate the news with billions of dollars in funding invested to combine AI with machine learning and data science across many disciplines, including medicine and healthcare. Within the context…

News from the EMA - Volume 26, Issue

Conditional marketing authorisations give patients access to important new medicines earlier January 23, 2017 – Conditional marketing authorisation (CMA) can speed up access to medicines for patients with unmet medical needs in the European Union…

Public perceptions of health information generated by AI: A research study - Volume 34, Issue

Artificial intelligence (AI) integration in clinical practice has intensified in the last few years, from systems analysing and interpreting existing data to generative AI systems capable of creating new information and offering new possibilities…

Patient-reported outcomes: How useful are they? - Volume 26, Issue

Patient-reported outcomes (PROs) are any report on the status of a patient’s health condition as told by the patient him or herself or through an interview, without any interpretation by a clinician or anyone else. They generate information on those…

Passing the torch - Volume 21, Issue

This issue is the first where I will be serving as Editor-in-Chief of Medical Writing (MEW). Elise Langdon-Neuner, Editor-in-Chief since 2004, will be stepping down. This is yet another step in the evolution of the journal.

For those of you unfamili…

CORE Reference – a tool for modern clinical study reports in an era of increasing transparency and disclosure - Volume 27, Issue

CORE Reference (www.core-reference.org) facilitates the authoring of a content-driven clinical study report (CSR) that is as “public disclosure-ready” as possible. It has potential to increase the quality of final CSRs and enhance consistency within…

Connecting the dots across the writing continuum - Volume 32, Issue

A medical writer has a unique opportunity to be involved with documents across the various stages of a product’s lifecycle. At the start of their careers, writers typically specialise in documents that are created in a particular phase of drug…