Medical Communications - Volume 27, Issue

In a follow-up to the excellent article from Douglas Fiebig on how to use your review cycle effectively, this issue presents an extremely insightful article from Diana Radovan on how to help reviewers to communicate better with writers. Diana…

Medical Communications - Volume 24, Issue

Dear all, However experienced you are, and whatever ‘level’ medical writer you may be, we all share the same pain… document review processes. Every medical writer has at least one horror story related to review cycles going awry, and the mere…

Transferring regulation into practice: The challenges of the new layperson summary of clinical trial results - Volume 24, Issue

The new European Clinical Trials Regulation, published on 27 May 2014, requires sponsors to provide summary results of clinical trials in a format that is understandable to laypersons. The lay summary is to be made publicly available in the yet to…

French breast implants, the Medical Device Regulation, and a theoretical case study - Volume 26, Issue

Abstract The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when…

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…

Publication of clinical trial protocols and statistical analysis plans on ClinicalTrials.gov - Volume 28, Issue

According to the final rule on “Clinical Trials Registration and Results Information Submission”, clinical trial protocols and statistical analysis plans have to be published on ClinicalTrials.gov. The requirement affects all applicable clinical…

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…

The regulatory-HTA decision-making interface: What the medical writer should know - Volume 30, Issue

For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine while the health technology assessment (HTA) bodies assess…

Datavision™ – What do medical writers need to know? - Volume 23, Issue

Datavision™ is a publication planning software tool that is widely used across the healthcare industry to manage publication programmes. Medical writers are one of the key Datavision user groups, and need to know how to use the elements of the…

Medical Communication - Volume 22, Issue

Introducing the Medical Communication section: The wild side of medical writing! Hello and welcome to a brand spanking new section of Medical Writing. When the Editor of Medical Writing, Phil Leventhal, approached me to create a new section,…