Scientific advice procedures in the EU – an overview ofthe regulatory background - Volume 29, Issue

The prerequisite for obtaining marketing authorisation is an appropriate and robust data package that demonstrates a medicinal product’s quality and its efficacy and safety in the proposed indication. Pharmaceutical companies can face regulatory…

Writing for lay audiences - Volume 24, Issue

For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…

News from the EMA - Volume 27, Issue

April 12, 2018 – The European Medicines Agency's (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as…

Medical Communications and Writing for Patients - Volume 30, Issue

Dear All,

As I write this, at least some of us are likely to still be in some form of lockdown or quarantine. I pray that you and your families are all managing to stay as sane as possible, and I sincerely hope that you all stay safe and healthy.

I…

Out on Our Own - Volume 24, Issue

With spring comes a renewed sense of optimism. A good time, perhaps, to review where we are in our businesses and consider how we can improve. Michelle Storm Lane of the Association of Independent Professionals and the Self Employed (IPSE) provides…

News from the EMA - Volume 28, Issue

October 5, 2018 and November 16, 2018 – Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Grampositive classes. EMA’s Pharmacovigilance Risk Assessment Committee…

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,…

Writing for Patients - Volume 29, Issue

The first thing we must say is a huge “thank you” to Dr Juan Garcia Burgos and Mr Paul Blake for taking the time in an unprecedentedly manic year for the EMA to write a foreword for this issue of Medical Writing. The fact that they have prioritised…

Good Writing Practice - Volume 26, Issue

Conceptual component omission is a distraction to a content expert who expects specific argumentative conceptual components in the various sections of a journal article. As evidence, some of the components have become standardised in structured…

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:…