Overview Digital health has grown exponentially as governments and other payers grapple with how to provide the best possible health outcomes at affordable costs. We believe that every healthcare decision should be informed by the best scientific research derived from rigorous, proven methodologies. In today’s world, healthcare decision [...]
Overview Genome editing has revolutionized our ability to modify the genome of (quite) any biological organism. In particular, it opens up new possibilities for the treatment of various diseases in humans like rare genetic diseases, cancer or HIV. Today, what alterations can we really achieve? What risks can [...]
Overview The direct interaction between patients / users of pharmaceutical products and the Pharmaceutical Companies has had a big increase since the widespread use of the Internet and social media. In parallel, the requirements of the competent authorities towards the exhaustive collection and management of any adverse events [...]
Some of the hot topics Analytical instruments and computerised systems operating in regulated laboratories must be fit for intended use. This is achieved by using a combination of analytical instrument qualification (AIQ) and computerised system validation (CSV). In the current regulatory [...]
Overview This 2 day programme is intensive, and aimed at participants who wish to understand the various legal aspects of M&A in its different facets, it addresses the deal process, key documents including the Share Purchase Agreement, Disclosure Letter, specific issues Due Diligence in Life Sciences including IP, [...]
Some of the hot topics The intentions of the medical device law & legal definitions Classification of SW devices under the regulation and under the standard IEC 62304 Requirements, regulations, rules and standards pertaining to Risk analysis & General Safety PMS planning, gathering and turning PMS into valuable [...]
Overview This 2-day intensive programme is aimed at participants who wish to understand the various legal and practical aspects of commercial contracts in its different facets, and minimise their organisation to exposure to potential expensive disputes, it addresses the background law, key documents including the Joint Venture Agreement, [...]
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 Healthcare landscape is changing drastically due to the emergence of new technologies. Treatment is diverging from the general applications paradigm we were subjected in the past to a personalization for each patient and each disease type. This course will present a general overview on precision medicine with [...]
Overview Nowadays, for as much as 95% of the 7 000 to 10 000 rare diseases that exist, there are no approved therapies. Of the estimated 400 M people worldwide afflicted with a rare disease, 50% are children. Cell and gene therapies have emerged as a new treatment [...]
