Veterinary Medical Writing - Volume 28, Issue

Like many medical writers, I started in another career first. For me, it was practising veterinary medicine in a clinic, then going into clinical research in humans, and then on to medical writing. Designing clinical trials, sample size…

Editorial - Volume 29, Issue

Data are economic assets that power the so-called fourth industrial revolution. The healthcare industry is at the forefront of this “data economy”. Medical writers should understand how to use these data appropriately and responsibly. This issue 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…

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…

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…

Changing methods to assess targeted therapies in oncology - Volume 27, Issue

New methods have been developed to evaluate targeted therapies, since the classic sequence – phase I, toxicity; phase II, efficacy; phase III, comparison with standard treat ment – is no longer effective for evaluating these new treatments. In…