Regulatory Writing Developments in paediatric regulation - Volume 22, Issue

Recently, both sides of the Atlantic have seen developments in paediatric regulation. In Europe, the EMA has published a new template for the paediatric investigation plan (PIP), which should help dispel some (but by no means all) doubts and…

Pharmacovigilance medical writing: An evolving profession - Volume 24, Issue

The preparation of pharmacovigilance documents is a global and cross-functional activity. The pharmacovigilance medical writer has a key position in this complex activity, leading the whole document creation process. This process includes drafting…

AMWA – EMWA – ISMPP Joint Position Statement on Predatory Publishing - Volume 28, Issue

The American Medical Writers Association (AMWA), the European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) recognise the challenges to scientific publishing being posed by predatory…

An introduction to little-known aspects of nonclinical regulatory writing - Volume 26, Issue

Nonclinical evaluation is a key component of drug development. Traditionally, scientists have prepared much of the written regulatory documentation, with dedicated nonclinical writing being a niche profession. This is changing – the demand for…

Ghostwriting prevalence among AMWA and EMWA members (2005 to 2014) - Volume 25, Issue

Ghostwriting, defined as undisclosed substantial contributions by medical writers, is considered to be unethical by the American Medical Writers Association (AMWA), EMWA, and other professional associations.

Out On Our Own - Volume 22, Issue

We are all riding high after meeting in Manchester at the EMWA conference in May 2013. It was wonderful to see so many colleagues coming together and enjoying the new-look events that EMWA offered us for the first time. Both the Symposium Day, and Ka…

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…

The new PubMed – underestimated regulatory obstacles - Volume 29, Issue

NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval…

EMWA News - Volume 28, Issue

On July 29, EMWA, together with the American Medical Writers Association (AMWA) and the International Society for Medical Publication Professionals (ISMPP), issued a joint position statement on the dangers of predatory publishing (see p. 34 of this…

Announcing the Geoff Hall Memorial Scholarships - Volume 22, Issue

At the conference dinner in Manchester this year, the creation of two very special scholarships was announced. The scholarships are in memory of one of the founding fathers of EMWA, Geoff Hall, who sadly passed away in 2010. Geoff was not only a…