News from the EMA - Volume 32, Issue

Anuradha Alahari (section editor)   EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo OPEN framework extended to a wider range of medicines Global regulators agree on way forward to adapt COVID-19 vaccines to…

Carbon footprint of clinical trials: a high-level literature review - Volume 31, Issue

Thousands of clinical trials are conducted globally each year. Yet, little is known about their environmental impact. This paper presents the results of a high-level literature review of the carbon footprint of clinical trials. Five papers were…

“Follow the Sun” writing: A hybrid operating model to optimize collaboration and efficiency - Volume 33, Issue

Time, quality, and accuracy are of the essence for expeditious global regulatory submissions. An around-the-clock, 24/7, global medical writing model has been developed that allows efficient development of high-quality documents with appreciable…

Message from the President - Volume 22, Issue

Dear Medical Writers It is time for me to give you another brief update on the activities of the EMWA Executive Committee (EC) and our plans for 2013, as well as a short preview on the spring conference in Manchester. The autumn conference…

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 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…

Subcontracting: Not for the faint of heart - Volume 28, Issue

Subcontracting can be the answer to a successful freelancer’s prayers, or the opportunity to work harder than you have ever worked before for less money than you made when you were a struggling newbie. The potential advantages of subcontracting are…

EU Regulations - Volume 29, Issue

Medical writing for cancer trials and submissions - Volume 21, Issue

Cancer is currently a high-priority area for drug development. Most cancers are immediately life-threatening diseases demanding urgent treatment and therapies are usually highly toxic. This poses a range of specific challenges for the ethical…

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:…