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…

Medical writing in the era of artificial intelligence - Volume 28, Issue

The increasing amount of data available together with advances in computer science are converting computers from simple tools that execute commands into self-taught, self correcting machines that make decisions. This is the beginning of the era of…

Profile: An interview with Art Gertel on the Budapest Working Group - Volume 24, Issue

Art Gertel (AG), with nearly 40 years of increasingly senior management level positions in the pharmaceutical industry, is an expert in the preparation of large, complex corporate and regulatory documents and is thoroughly familiar with relevant US,…

EMWA social media team - Volume 23, Issue

As most of you already know, EMWA is currently using social media to interact with its members on a daily basis, to share information and promote discussions. Social media are not just sources of information but also ways of interacting with…

Regulatory Writing Briefing documents: A case apart - Volume 24, Issue

Health authority briefing documents (also known as briefing packs, briefing packages, and briefing books) are documents prepared by a pharmaceutical company to support its interactions (e.g. pre-submission meetings, requests for scientific advice,…

Translation - Volume 33, Issue

Writing applications for Paediatric Investigation Plans and waivers - Volume 21, Issue

Under EU legislation, a Paediatric Investigation Plan (PIP) and/or a waiver must be agreed in advance with the European Medicines Agency (EMA), for all new medicinal products seeking marketing authorization; the same applies for already authorized…

The Webscout - Volume 21, Issue

Issues in paediatrics Infants, children, and adolescents have special needs regarding their health and care. They are not ‘little adults’. The spectrum of illnesses differs from that known in adults. Just think of teething problems like…

Adverse event reporting: A brief overview of MedDRA - Volume 23, Issue

Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a…

In the Bookstores - Volume 29, Issue

Last year, I wrote my first poem – 10 lines of free verse that, after three rejections and 229 days in queue, was purchased and published. Although I have been selling short stories since 2016, poetry is something new for me, undiscovered territory,…