Microediting – details matter Quality, authority, and reputation: The value of microediting - Volume 27, Issue

Microediting aims to ensure consistency aswell as accuracy within a document and across a document series. Also known as technical editing or mechanical editing, it is an important stage in editing, needed to gain and retain a reader’s interest and…

Same but different: Basic tools for biosimilar and generic pharmacovigilance writing - Volume 28, Issue

Biosimilars are medicinal products, which are highly similar to an already authorised biological product; generics are identical copies of an already authorised chemical entity. As for any other medicinal product,biosimilars and generics require the…

My medical writing journey: How I discovered self-mentoring and used it to improve my career and life - Volume 30, Issue

Medical writers can greatly benefit from receiving mentorship, mentoring others, and learning how to keep themselves accountable through self mentoring. Through mentorship, they can get unique advice to accelerate their career development and…

Pesticide dossiers, an opportunity for medical writers - Volume 23, Issue

Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a…

Someone in your corner: Musings of a mentor and mentee - Volume 30, Issue

What is a modern mentorship, how do you make it work, and what does gardening have to do with it? Let us take you on a tour of the growing garden of our own modern mentorship, showing how we as a medical writer (Lillian Sandø; mentor) and a clinical…

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,…

Getting Your Foot in the Door - Volume 30, Issue

Below, two young colleagues share their experiences as mentees and the benefits they gained from such programmes. First, Geneviève Laumen tells it from the perspective of being part of an organised, structured mentorship. Next, Ivana Turek shares…

Regulatory Writing - Volume 24, Issue

The Transatlantic Trade and Investment Partnership (TTIP) has attracted increasing controversy, particularly in Europe. The TTIP is a trade agreement under negotiation between the United States and the European Union, and affects three main areas:…

Regulatory Matters - Volume 30, Issue

Calling all medical writers:

Focus your writing with lean authoring

In today’s medical writing environment, authors are routinely faced with expedited timelines to write documents about highly complex studies with overwhelming amounts of data. Revi…

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…