Some of the hot topics The interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environments and the functional priorities is a key success factor. Conflicts, mostly resulting [...]
Overview The introduction of the Quality by Design concept in the early 2000’s has changed the paradigm of product and process development for recombinant biotherapeutics, switching from the process makes the product to the product makes the process. The Quality by Design approach starts by the understanding of [...]
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 The course aims to explain the legal and compliance background to risk management, before considering in a non-mathematical way the core principles and processes of managing risk. Case studies will be used and the emphasis of the course is on developing a comprehensive understanding of the subject [...]
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 increasing demand for digitalization is currently challenging large to small sized company globally and hardly any company can ignore the digitalization trends today. This masterclass will provide delegates clarity of which prerequisites need to be considered to prepare for the demanding task. This course will provide [...]
From auditor to auditor: which areas of your company do you audit? The most common answers I’ve heard are two: a) the accounts that are related to money such as banks, petty cash, payments, purchases, etc. and b) the accounts that have a higher balance because when auditing them, a higher amount is being covered. [...]
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 The Leadership in Safety In-house Training is based upon our multi-award winning Leadership programme, reconfigured to meet the needs of business as a consequence of the Global Coronavirus Pandemic. The virtual workshop takes the lessons and [...]
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 [...]
