An interview with Julia Cooper: Insights and experiences from leading a global medical writing team - Volume 33, Issue

Julia Cooper, PhD, is the Corporate Vice President and Head of Medical Writing Services at Parexel. In this interview, she shares her insights on the different aspects of leading a global medical writing team and on how she and her team at Parexel…

Essential investments in optimising clinical research for rare disease - Volume 34, Issue

The complexities associated with clinical trials for (ultra) rare diseases include regulatory and logistical hurdles and the challenge of building trusting relationships with health authorities, patients, and clinicians. Significant obstacles…

Writing in plain language for the Summary of Safety and Clinical Performance: Communicating medical device safety and performance data to patients - Volume 34, Issue

Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…

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…

Good clinical practice (GCP): A universal call for ethics in biomedical research - Volume 23, Issue

Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with…

Optimizing the value of regulatory writers - Volume 31, Issue

An expanding need for clinical documentation and regulatory health authority interactions during drug development has drawn increased attention to the role of the regulatory medical writer. This role is frequently misunderstood and poorly…

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

Thirty-seventh EMWA Conference, 7–9 November 2013, Barcelona, Spain - Volume 22, Issue

EMWA's 37th Conference will be held at the Fira Palace Hotel in Barcelona from Thursday, 7 November to Saturday, 9 November 2013. The Fira Palace Hotel is ideally situated in the trade-fair and exhibition area and is a short walk from Barcelona's…

News from the EMA - Volume 23, Issue

Update from the European Medicines Agency on development of its policy on publication and access to clinical-trial data   From the European Medicines Agency, 13 November 2013 – The European Medicines Agency is currently reviewing and analysing…

EMWA social media team - Volume 23, Issue