Currently, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for just under a third of applications and updates for European medicinal product marketing authorisations – but on 29 March 2019 the UK will no longer be part of the European Union (EU). I was struck by the enormity…
Having recently returned from Seoul, it struck me that the Korean beauty and cosmetics market is markedly different from Western markets. Whilst Western culture – particularly the US – has had an impact on beauty ideals, there is an exciting revolution of South Korean beauty and cosmetic products which are…
On returning from Vienna and PDA’s excellent Universe of Pre-filled Syringes and Injection Devices event, I wanted to share my thoughts on some of the themes I saw emerging from the conference:1. Hearing the voice of the patient direct – during the pre-conference workshop, Markus Bauss from SHL presented two talks by…
As part of our review of the new European Medical Devices Regulation (MDR) earlier this year, one of the topics that caught our eye was the expansion and clarification of the rules regarding clinical data for medical devices.The difference between a clinical investigation and a clinical evaluation Many people colloquially…
Globally, about a third of all the food produced for human consumption every year is wasted – roughly 1.3 billion tonnes – according to the Food and Agriculture Organization of the United Nations. Consumers in richer countries waste almost as much food (222 million tonnes) each year as the entire…
It took 13 years and £2 billion to sequence the human genome back in 2003. Fast forward 15 years to today and next-generation sequencing (NGS) can do it for less than $1,000 in a matter of days. High-throughput sequencing technologies, computational power and data-mining techniques have opened up a whole…
It weighs 7.5 tonnes and is powered by both a jet engine and a rocket, which together will produce over 135,000 bhp – more than six times the power of all the Formula 1 cars on a starting grid put together. It has temperatures inside the rocket that reach 3,000°C…
My family and I are eight weeks into our life in a new country, with a new house, a new car and a new phone. Our new neighbours (or I should say ‘neighbors’) have been hugely welcoming. But actually immersing and integrating ourselves into local processes and systems has been…
The numbers are huge. Pharma companies are losing an estimated $637 billion each year because of medication non-adherence, according to a report by consulting firm Capgemini and medication adherence company HealthPrize Technologies. And improved adherence to diabetes medication programmes alone could avert 699,000 emergency department visits and 341,000 hospitalisations annually…
“A new generation of Chinese entrepreneurs will have a powerful impact on industries and consumers worldwide” – a very assertive headline introducing a recent Economist article to be read by anyone still doubting that China is now on a fast track to being a world leader in innovation.In fields such…
Digital is reinventing whole industries. In sector after sector we are seeing incumbent market leaders threatened, and sometimes displaced, by new entrants who can deploy digital technologies quickly and effectively – because they have the new skills and don’t have to protect their cash cows and legacy infrastructure. Advertising is…
The new European Medical Devices Regulation (MDR) introduced by the European Commission (EC) has led to a lot of discussion around the implications for getting products on to the European market. But what about products that are already on the market? What does the new regulation mean for these so-called…