Overview Today we can no longer afford to undertake randomized effectiveness trials that cost tens or hundreds of millions of dollars. But today we also have registries and other powerful digital platforms. Today it may be possible to design and conduct megatrials with what we have: bigger data [...]

Overview As healthcare shifts from “volume to value” we are seeing a global trend of shifting medicines and technology pricing towards a value based paradigm. This comprehensive symposium will cover off “value based agreements” and innovative financial contracts between pharmaceutical manufactures and payers. We will go through VBA [...]

Overview The concept and practices of Corporate Social Responsibility have evolved in the last two decades at an increasing pace. Shaped by the public pressure and the exigencies of the industry, the CSR/ Sustainability programs became more and more focused on social engagement and consistency in corporate response. [...]

Overview Twenty-five years ago, software did not feature significantly in medical device legislation. Thirteen years ago it was added as a serious afterthought. As Europe moves to the new Medical Device Regulations, software is recognised throughout the General Safety and Performance Requirements. It has its own rules in [...]

Overview Manufacturing processes should be validated prior to initiate commercial manufacturing. Regulatory bodies expect that the manufacturer understand the process so that quality, safety and efficacy of the product are designed or built into the product through the appropriate control of each manufacturing process steps. Today, process validation [...]