Biomanufacturing and One Health - Volume 32, Issue

At a time when the scope of One Health is expanding, the term “biomanufacturing” has taken on new significance as a new route to more sustainable manufacturing in the face of the current overwhelming reliance on fossil resources for fuel, energy,…

Veterinary Medical Writing - Volume 33, Issue

What’s up, doc? Defining a use for graphic medicine in veterinary communications Author: Louisa Marcombes This article aims to make the case for graphic medicine – comics in healthcare –and attempt to define their use in the veterinary field.…

The medical writers role in health technology assessment submissions - Volume 30, Issue

Writing health technology assessment (HTA) submissions is a challenging and rewarding area of medical writing, being part of the process of giving patients access to new medicines. Submission requirements differ between countries but all require…

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…

Anonymisation: A new challenge for medical writers - Volume 27, Issue

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…

55th EMWA Conference - Volume 32, Issue

The 55th EMWA Conference took place on May 9–13, 2023, in Prague. With more than 400 participants from across Europe and the world, it was a rousing success. Topics of workshops and presentations ranged from the latest in regulatory writing and…

From EMWA's new President Carola Kraus - Volume 30, Issue

A year of EMWA firsts has passed and while we are still not in a post-pandemic phase, one can see that our profession has regained its momentum. In the past, you might have experienced the need to explain to family members and friends what “medical…

Out On Our Own - Volume 24, Issue

Editorial

All of us are aware by now that we can't live without technology and not only at work. With advice, aids, appliances and apps in abundance, we are at the point where we can't see the wood for the trees. Thank goodness we have advice from M…

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…

Regulatory Writing: Review process in regulatory writing - Volume 24, Issue

Recently, Phil Leventhal posed the question ‘What does it take to go from being a good medical writer to an excellent one?’ on EMWA's LinkedIn Discussion Group. My impression is that the responses were written largely with medical communications…