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 befor...

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 end on 31st December 2020. During...

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 enormous ta...

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...

New waves of biological drugs may vastly improve treatment for many diseases, but not without adapted delivery devices for effective subcutaneous administration. Geo...

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

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

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 years. To ...