Matthias Bicker, Daniel Haines, and Uwe Rothhaar  

What policies and processes should be adopted for the optimal cold chain management of vaccines. This task is more immense, complex and time-critical than ever …

The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an …

Although acknowledged as benefiting society, science is unfortunately conducted and consumed by a relatively small number of people who are often thought of as the …

When it was announced that the Medical Device Directive (MDD) would be replaced by the Medical Device Regulation (MDR) several years ago, it triggered an …

The European Medical Device Regulation 2017/745 (MDR) entered into force on 26th May 2017, bringing together requirements from the Medical Devices Directive (MDD, 93/42/EEC), Active …

New waves of biological drugs may vastly improve treatment for many diseases, but not without adapted delivery devices for effective subcutaneous administration. George I’ons at …

Once manufacturers, regulators and clinicians agree on consistent representation and description of the various attributes of a drug – the promise of ISO IDMP (Identification …

The term “optimise” is often applied to complex manufacturing, automation, and business processes. It suggests that the most efficient function of all the elements of …

The LAL method, which is the industry standard for the detection of gram-negative bacterial endotoxin, was preceded by the rabbit pyrogen test by about 30 …