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This author has not written his bio yet.
But we are proud to say that Michael Kuhrt contributed 541 entries already.
In the last few years, the regulatory landscape overseeing manufacturing process validation has faced major overhauls in two ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) regions.
This summer saw the first deadline for the new SME Instrument, and the evaluation feedback from the European Commission could be a wake-up call for small companies across Europe.
External innovation is one of the pharmaceutical industry’s solutions for overcoming patent cliffs and gaps in innovation. It’s based on the insight that the majority of innovations in this sector do not have their origin in Big Pharma, but come from academia and small biotech companies.
The launch of Horizon2020 and close of the first deadlines in February has shown the appetite of Europe’s researchers from industry and academia for funding.
Research and innovation models are changing dramatically. The emergence of platforms such as advanced therapeutics is accelerating a change from innovation within big centres and universities to smaller, decentralised and more focused units.
There are sinister moves in the world of data protection, and I need to mobilise you my crack squad of guerrilla scientists. The EC is showing its ugly face, and it’s going to impact you.
As we all know, the European Commission is under intense pressure to reduce costs and shed the image of being a gravy train. This is a favourite topic at the national level in the ongoing fight against the reign of terror from Brussels.
There’s no question that Europe’s biotech sector produces high-quality science. We have world-class research organisations and start-ups, as witnessed by the number of alliances with Big Pharma and the number of products being registered.
Shhhhh, is that the sound of a chicken coming home to roost in Switzerland? Worried? If you are a scientist working internationally, you should be and not just because you want a job in Switzerland.
In October 2012, the European Commission issued a communication on its new Industrial policy identifying biotechnology as one of six Key Enabling Technologies. Biotech will be an important tool in helping Europe deliver on its Europe 2020 strategy of creating an innovative, resource-efficient, smart, sustainable and inclusive economy.